Interim / Quarterly Report • Apr 24, 2025
Interim / Quarterly Report
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XVIVO Perfusion AB (publ)
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At XVIVO, we have millions of reasons to go to work every day, namely all the people who desperately are in need of new lungs, a new kidney, a new liver, or a new heart. Founded in 1998, XVIVO is the only MedTech company dedicated to extending the life of all major organs - so transplant teams around the world can save more lives. X\/I\/O is a global company headquartered in Gothenburg, Sweden.

170.000
organ transplants each year, only
10%
With only
of total global demand is met
XVIVO's offering increases availability of transplantable organs
X\/I\/O's business concept is to develop and market effective, innovative technology for preserving, transporting and assessing organs outside the body while avvaiting transplant, and to facilitate the transplant process by offering service solutions to support hospitals.
To become the global leader in the preservation of organs outside the body for all major organs (lung, heart, liver and kidney) and establish machine perfusion as the standard method for preserving, transporting and assessing donated organs ahead of transplantation.
VVe believe in an extended life of organs. Nobody should die waiting for a new organ.
Investing in XVIVO means being part of a journey to solve the global organ shortage crisis while driving strong, sustainable growth. With proven technologies and a solid track record on execution, XVIVO is uniquely positioned to lead the future of transplantation and unlock the untapped market potential.
The XVIVO share is listed on NASDAQ Stockholm and traded under the XVIVO ticker
CEO comment
Net sales in the first quarter amounted to SEK 219 million, corresponding to organic growth of 14 percent in local currency. Abdominal grew by 28 percent, Thoracic by 16 percent, while Services decreased by 6 percent. Topline growth resulted in an improved adjusted EBITDA margin of 21 percent (20) in a quarter where we continued to expand our customer-facing organization and invest to strengthen back-end.

Christoffer Rosenblad, CEO
In an ever-changing world, where each company must find its way to navigate successfully, I will start by addressing the global trade policy situation. First and foremost, I want to emphasize that regardless of any changes in global trade policies, our primary commitment remains to all patients and their families worldwide who desperately need a new organ. Secondly, transplantation is key to reducing government spending on healthcare, and therefore XVIVO works persistently to make sure clinics have the best opportunity to both save lives and reduce costs. This is why XVIVO exists.
Regarding the current tariffs imposed on the US market, we have both short- and long-term plans for how to navigate the emerging landscape. Our XPS machine and parts of the lung disposables are manufactured in the US and will remain largely unaffected by these tariffs. Our kidney technology, as well as other perfusion and preservation solutions for lungs, are manufactured in Europe, and in the short-term price adjustments are needed to maintain profitability. Our heart and liver technologies have not yet been commercialized in the US, which provides us with some flexibility. In the medium to long-term, the company aims to set up machine manufacturing in both Europe and the US in order to increase on-time delivery and build reserve capacity.
From a regulatory perspective, the year started off on a very positive note with several key milestones achieved during the first quarter. I am very pleased to announce that the PRESERVE CAP (Continued Access Protocol) Study has received FDA approval to enroll up to 60 heart patients during six months across the 26 sites that previously participated in the PRESERVE Trial. Enrollment of the first patient is expected in the second quarter this year.
Additionally, our Liver IDE application was approved by the FDA in record time. The trial is set to begin in the third quarter and will include 215 patients across 20 American transplant clinics.
We also reached a milestone in Canada following MDSAP approval. Our product offering is now available for Canadian kidney, liver, and lung patients, and we recently hired our first Canadian employee. Our heart technology will be introduced in Canada as well, once we obtain the European CE mark.
In European patients, clinics and XVIVO are awaiting final approval for the CE mark of Heart. We maintain a constructive dialogue with our notified body as well as the two medical agencies -
"Regardless of any changes in global trade policies, our primary commitment remains to all patients and their families worldwide who desperately need a new organ."
EMA and the Swedish Medical Products Agency (MPA). XVIVO is focusing on what we can effect, which is fast and high-quality answers to the agencies and launch readiness.
We are currently looking forward to ISHLT in Boston in the last week of April, where the 12month data from our European heart trial will be presented. 3-month data published in The Lancet last year showed a 76 percent risk reduction in severe primary graft dysfunction (PGD), which is a remarkable result as severe PGD is the key indicator of both short- and long-term survival.
Clinical data using the XVIVO Heart technology shows that cold (hypothermic) oxygenated perfusion (HOPE) is favorable and should be the preferred method for all heart transplants. Our ambition is for the Heart technology to become the new gold standard-just as PERFADEX has been for cold static lung preservation for decades. Early-stage adoption in Australia/New Zeeland proves that we are serious; last year, 28 percent of all transplanted hearts in Australia/New Zealand were preserved using XVIVO Heart Assist Transport-and when looking only at DBD hearts, that number rises to 33 percent. The first quarter of 2025 also started on a high note, with 61 percent sales growth in Australia/New Zealand.
Lung sales started somewhat weaker than expected this year. Growth was hampered by a relatively strong comparison quarter in 2024, and limited access to new XPSs during the previous six months due to limitations in the supply chain. Our dedicated work led to the delivery of XPS machines to four new customers at the end of March - two in the US and two in Europe. We continue to see growing interest in XPS from new transplant clinics and are optimistic about 2025. However, the limited production rate is expected to continue in Q2-Q3 with approximately three machines per quarter.
During the first quarter, two EVLP studies from the US were published. The first study' demonstrated that EVLP with STEEN Solution is feasible also for high-risk patients and that STEEN Solution with the XPS outperforms the competition in terms of survival. The second study2 demonstrated that, for centers performing more than three EVLPs per year, the procedure was associated with a lower cost per transplant.
In Europe, the abdominal portfolio continued to perform well in the first quarter with Kidney growing around 50 percent and Liver growing by 25 percent. In the US, we are beginning to see early signs of progress for Kidney Assist Transport, with growth of 108 percent in disposables in year-on-year terms. However, there are two key areas we need to improve in order to fully address the market: design updates and collection of US patient data. The work is on-going.
Providing various service models to transplant clinics rather than just products is becoming increasingly important, especially in the US, in order to be a true partner and support clinics in strengthening and expanding their transplant programs. The service industry in the US is developing rapidly. XVIVO has important platforms in place and will conduct a complete strategic overview of our service and product offering in the US during the first half of 2025.
As we look ahead, we remain committed to our vision that 'nobody should die waiting for a new organ.' The achievements of the past year, combined with the exciting opportunities ahead, position XVIVO for rapid yet sustained growth. I am confident that 2025 will be another highly impactful year for XVIVO.
Christoffer Rosenblad, CEO
1 https://doi.org/10.1016/j.jtcvs.2024.10.041
2 https://doi.org/10.1111/ctr.70096
In order to document the safety and efficacy of our products, we conduct pre-clinical and clinical trials in collaboration with leading researchers and clinics. Clinical data is the foundation for obtaining market approval for the products, but is also critical for demonstrating their value to our target groups.

In Europe, XVVO included the last patient in the heart preservation study NHP2019 in total 202 patients from 15 transplanation clinics in 8 European countries enrolled. Compelling 3-month data was published in The Lancet in August 2024. 12-month data will be presented at ISHLT in Boston at the end of April 2025. XVIVO is currently awaiting regulatory approvals required to apply for CE marking. In selected European markets, XVIVO's heart technology is currently available use provisions. Commercial launch in Europe is expected in 2025, pending CE marking approval.
In Australia and New Zealand, a study involving 36 patients was conducted across in 2023. The study focused on Iong-distance donors and transplants in which the heart is extended out-of-body time. The results were published in the Journal of Heart & Lung Transplantation in November 2023. XVIVO's heart technology is currently being sold in Australia under a special access scheme. In 2024, the technology was used in approximately one-third of all heart transplants in Australia and New Zealand is expected to follow one CE marking has been obtained.
In the US, the final transplant procedure in the PRESERVE study was performed in November 2024. The study included 141 patients across 20 transplant centers and was fully enrolled in just 13 morths due to strong interest. Follow-up period, concluding in November 2025, the data will be analyzed and form the basis for a PMA marketing application to the FDA. XVIVO is planning for a commercial launch in the United States in early 2027, subject to obtaining PMA approval.
In the US, Liver Assist has been granted Breakthrough Designation by the FDA, and in February 2025, the FDA application for DeLIVER a multicenter study involving 215 patients in need of liver transplant centers. The first patient is expected to be included during the third quarter of 2025. The timeline for PMA approval and subsequent commercial launch can be estimated with greater accuracy once patient enrollment is complete and the 12-month follow-up period has concluded.
| Compilation of net sales and KPIs | |||
|---|---|---|---|
| January-March | January-March | Full year | |
| SEK Thousands | 2025 | 2024 | 2024 |
| Net Sales Thoracic | 141 698 | 120 886 | 555 235 |
| Net Sales Abdominal | 56 560 | 43 998 | 179 420 |
| Net Sales Services | 20 330 | 21 138 | 87 760 |
| Net Sales Total | 218 588 | 186 022 | 822 415 |
| Gross profit Thoracic | 116 858 | 97 803 | 463 597 |
| Gross margin Thoracic, % | 82% | 81% | 83% |
| Gross profit Abdominal Gross margin Abdominal, % |
35 875 63% |
29 688 67% |
117 340 65% |
| Gross profit Services | 7 641 | 7 615 | 35 478 |
| 38% | |||
| Gross margin Services, % Gross profit Total |
160 374 | 36% 135 106 |
40% 616 415 |
| Gross margin Total, % | 73% | 73% | 75% |
| Selling expenses | -73 710 | -64 584 | -283 982 |
| Administrative expenses | -23 023 | -21 409 | -95 788 |
| Research and development expenses | -35 478 | -30 588 | -148 329 |
| Other operating income and expenses | -1 597 | 468 | 37 |
| Operating Income (EBIT) | 26 566 | 18 993 | 88 353 |
| EBIT, % | 12% | 10% | 11% |
| EBIT (adjusted) 1) | 29 767 | 19 937 | 115 633 |
| EBIT (adjusted), % | 14% | 11% | 14% |
| Amortization and depreciation cost of goods sold | 561 | 513 | 1 956 |
| Amortization and depreciation administrative expenses | 1 265 | 1 375 | 24 828 |
| Amortization and depreciation research and development expenses | 7 917 | 9 462 | 5 181 |
| Amortization and depreciation selling expenses | 6 658 | 5 599 | 55 751 |
| EBITDA (Operating income before depreciation and amortization) | 42 967 | 35 942 | 176 069 |
| EBITDA, % | 20% | 19% | 21% |
| EBITDA (adjusted) 1) | 46 168 | 36 886 | 183 058 |
| EBITDA (adjusted), % | 21% | 20% | 22% |
| 1) Adjusted for the effect of non-recurring costs of SEK -3.2 (-0.9) million for the quarter. For specification, see Reconciliation of alternative performance measures. |
|||
| Changes in Net Sales | |||
| SEK Thousands | January-March 2025 |
January-March 2024 |
Full year 2024 |
| Organic growth in local currency, % | 14 | 32 | 39 |
| Acquired growth, % | 2 | - | - |
| Currency effect, % | 2 | - | -1 |
| Total growth, % | 18 | 32 | 38 |
| Changes in Net Sales | |||
|---|---|---|---|
| January-March | January-March | Full year | |
| SEK Thousands | 2025 | 2024 | 2024 |
Net sales in the quarter amounted to SEK 218.6 million (186.0), an increase of 18 percent yearon-year, of which 14 percent derived from organic growth. The Business areas Thoracic and Abdominal delivered underlying sales growth in local currencies: Thoracic 16 percent and Abdominal 28 percent. Services delivered negative growth of -6 percent. For a description of development within each business area, see pages 10-11.
The total gross margin for the quarter was 73 percent (73). For comments regarding the margins in each business area, see pages 10-11.
Operating expenses by function were in line with the previous year in relation to net sales. Selling expenses in relation to total sales amounted to 34 percent (35) for the quarter. R&D expenses amounted to 16 percent (16) of sales, and administration expenses amounted to 11 percent (12) of sales. During the quarter, XVIVO continued to invest in its organization and intends to further expand both its team and customer offering over time to meet the growing interest in and demand for machine perfusion and related service solutions.
Operating income before depreciation and amortization (EBITDA) amounted to SEK 43.0 million (36.0), corresponding to an EBITDA margin of 20 percent (19). EBITDA was affected by acquisition and integration expenses related to the acquisition of FlowHawk totaling SEK -3.2 million (-0.9). Adjusting for these items, EBITDA amounted to SEK 46.2 million (36.9), corresponding to an adjusted EBITDA margin of 21 percent (20).
Operating income (EBIT) amounted to SEK 26.6 million (19.0). EBIT adjusted for the aforementioned specific expenses amounted to SEK 29.8 million (19.9) and an adjusted EBIT margin of 14 percent (11).
During the quarter, SEK 40.1 million (24.3) of development expenses were capitalized as intangible assets. The development expenses essentially related to expenses for R&D projects with the aim of obtaining regulatory approval in the US, Europe and Australia/New Zealand in heart and liver perfusion. Amortization of capitalized development expenditure was SEK 5.1 million (7.4) in the quarter.
Cash flow from operating activities for the quarter amounted to -SEK 15.3 million (1.6), impacted by increased working capital tied up due to higher sales and the annual payout of employee-related liabilities. Cash flow from investing activities amounted to SEK -58.9 million (-42.5), of which SEK -40.8 million (-24.5) was invested in intangible assets and SEK -18.2 million (-18.0) was invested in property, plant and equipment. Cash flow from financing activities amounted to net SEK -3.0 million (-2.4). Exchange rate differences impacted the cash flow for the quarter by SEK -22.5 million (8.3). Cash and cash equivalents at the end of the quarter amounted to SEK 315.9 million (511.2).
XVIVO
XVIVO's operations shall be conducted with sustainable and efficient capital structure. The company's equity/assets ratio is strong and amounted to 91 percent (89) at the end of the company's total credit facilities include a revolving credit facility, which stood at EUR 20 million (-) at the period, with EUR 0.0 million (0.0) drawn.
Net sales by business area (R12) SEKm


The Investigational Device Exemption (IDE) application for Liver Assist was submitted to the FDA at the end of January and approved within 30 days-thanks to thorough preparation and close collaboration with the agency to ensure a protocol that addresses key regulatory aspects. Like XVIVO Heart Assist Transport, Liver Assist has received Breakthrough Device Designation, a part of the FDA's program to expedite the development and review of technologies with the potential to significantly improve patient outcomes.
The upcoming clinical study, titled DELVER: A Prospective, Multi-Center, Single-Arm, Open Label Trial of Deceased Donor Livers Transplanted After HOPE with eXVIVO LIVER Perfusion will involve 215 patients across up to 20 US clinical centers.
The study will focus on two primary outcomes of early allograft dysfunction (EAD) and the number of patients with functioning liver transplants six months after transplantation. Patients in the study will receive liver donations from deceased donors either with extended criteria for brain death (ECD-DBD) or after circulatory death (DCD), where the organs have been preserved using dual hypothermic oxygenated perfusion (DHOPE) with Liver Assist.
The approval process with the institutional review boards (RB) and contract review are currently underway. The first patient is expected to be enrolled during the third quarter of 2025.
The PRESERVE CAP study (Continued Access Protocol) has received FDA approval to include up to 60 patients at the 26 clinical centers that previously participated in the PRESERVE study.
The CAP paves the way for so-called compassionate use and enables continued access to XVIVO Heart Assist Transport (XHAT) while the FDA reviews the company's application for market approval (PMA). The protocol allows study clinics to continue offering XHAT to patients who meet the original inclusion criteria, while safety and efficacy are evaluated by the FDA. The criteria and study design for the CAP study are unchanged compared to the previous IDE study, PRESERVE.
Interest in the CAP study has been strong among the participating clinics, and with ethical approval (IRB) currently under review, the first patient is expected to be enrolled during the second quarter of 2025.
| 500 400 300 200 |
||||
|---|---|---|---|---|
| SEK Thousands | January-March 2025 |
January-March 2024 |
Full year 2024 |
100 |
| Net sales | 141 698 | 120 886 | 555 235 | |
| Lung | 133 810 | 109 178 | 489 886 | 0 |
| Heart | 7 888 | 11 708 | 65 349 | Lung Heart |
| Gross margin, % | 82 | 81 | 83 | |


Machine perfusion, 60% Static preservation, 38% Other, 2%

North and South America 66% EMEA 27% APAC 7%
| January-March | January-March | Full year | 180 160 140 120 100 80 60 40 20 0 |
||
|---|---|---|---|---|---|
| SEK Thousands Net sales |
2025 56 560 |
2024 43 998 |
2024 179 420 |
||
| Liver | 42 655 | 33 362 | 126 813 | Liver Kidney |
|
| Kidney | 13 905 | 10 636 | 52 607 | ||
| Gross margin, % | 63 | 68 | 65 | ||
SEK Thousands 2025 2024 2024 Net sales 20 330 21 138 87 760 Gross margin, % 38 36 40
| January-March | January-March | Full year |
|---|---|---|


North and South America 13% EMEA 85% APAC 2%
Our greatest contribution to sustainability is creating opportunities to save more lives enhance the quality of life for patients and improve healthcare economics so that healthcare systems all over the world can afford to do even more. Our core business is based on our vision that nobody should die waiting for a new organ. For more detailed information regarding our sustainability work, see our 2024 Annual Report.
The XVIVO Group has 193 employees, of whom 97 are women and 96 men. Of these, 61 are employed in Sweden and 132 outside Sweden. The head office is located in Gothenburg, Sweden and we have active subsidiaries in the US, Netherlands, Italy, France, Brazil and Australia. XVIVO also has employees based in several other countries globally.
There were no related-party transactions during the period.
XVIVO works continuously to identify, evaluate, and manage risks in different systems and processes. Risk analyses are carried out continuously regarding normal operations and in connection with activities that are outside XVNO's regular quality system.
Global health crises, such as pandemics, can have a temporary negative impact on organ transplantation. The market risks that are deemed to have a particular impact on XVIVO's future progress are linked to the availability of financial and medical resources in cilnics around the world. Operational risks are risks that limit or prevent XVIVO from developing, manufacturing and selling highquality, efficient and safe products. The number of organ transplants is marginally affects. Mainly in new treatment methods, such as warm perfusion of lungs, slightly occurs during the summer months because there is less training and learning the summer vacation period. Legal and regulatory risks may arise from changes in legislation or policy decisions that may affect the Group's ability to conduct or develop the business. Financial risks include exchange rate risks.
More information regarding strategic and operational risks is described in the management report in our 2024 Annual Report.
The Annual General Meeting of XVIVO Perfusion AB (publ) will be held on April 25, 2025 at 1:00 p.m. CEST at the Swedish Exhibition & Congress Center in Gothenburg (Svenska Mässan). The following people have been appointed to be part of XVIVO Perfusion AB's Nomination Committee for the 2025 Annual General Meeting:
Henrik Blomquist, appointed by Bure Equity AB Thomas Ehlin, appointed by Fourth AP Fund Martin Lewin, appointed by Eccenovo AB Gösta Johannesson, Chairman of the Board
The appointment has been made in accordance with the current instructions regarding the principles for the nomination committee in the company. The shareholders who appointed the members of the Nomination Committee jointly represented 28.7 percent of all shares in the company on August 31, 2024.
Despite the uncertainty in the external environment, including potential trade barriers and possibly increased cost pressures in healthcare, we remain confident about 2025. The need for life-saving organ transplants continues to grow globally, and our technology is well-positioned to meet this demand. Transplantation care remains a priority in both the US and Europe-markets where we hold a leading position and have established partnerships. Our focus is on continuing to deliver innovative solutions that improve patient outcomes and streamline healthcare workflows. We are financially strong, with a clear strategy for profitable growth and continued expansion across all four solid organs. With a continued focus on quality, evidence, and customer value, we are confident that 2025 will be a step forward-both for us and for transplantation care.
For 2025, we see several kev milestones ahead of us, including the commercialization of our heart technology in Europe and Australia/New Zealand, as well as the inclusion of the first patient in our liver study in the US. In terms of sales, we anticipate that EVLP in the US, as well as liver and kidney in Europe, will be the primary drivers of sales growth throughout the year, until the US studies for heart and liver are fully underway and until we can launch our heart technology in Europe, which will happen as soon as we have obtained CE marking.
2025 will also be a year where we continue to invest in the future. The key regulatory investments for the next two years will be our US studies, and the PMA approval processes for heart and liver. We will also need to invest further in our commercial capacity in our key markets-proximity to the customer will be crucial in making machine perfusion the standard of care. One final investment area worth mentioning is inventory. To reliably meet the growing demand in the coming years, we need to build additional inventory for lung and liver, and this work was initiated in the first quarter of 2025. The company has increased its credit facilities to EUR 20 million to enable higher inventory buildup and increased accounts resulting from higher sales.
To summarize, we assess that the number of transplants in the world will continue to increase. Transplantation is lifesaving and has the potential to save significant money and resources for healthcare systems. Growth will be fueled by machine perfusion and service models that facilitate the work of transplantation clinics, and XVIVO will continue to invest in the significant existing market potential.
Mölndal, Sweden, April 24, 2025
Christoffer Rosenblad CFO
No events occurred after the end of the reporting period that affect the financial information in this report.
This report has not been reviewed by the company's auditors.
This information is information that XVIVO Perfusion AB (publ) is obliged to make public pursuant to the EU Market Abuse Requlation. The information was submitted for publication through the agency of the contact person set out below on April 24, 2025 at 7.30 am CEST.



CEO Christoffer Rosenblad and CFO Kristoffer Nordström will present the Interim Report in a conference call at 2.00 p.m. CEST on Thursday, April 24.
For access via conference call, click here
For access via webcast, click here

Contact
Christoffer Rosenblad, CEO tel: +46 735 19 21 59 email: [email protected]
Kristoffer Nordström, CFO tel: +1 484 437 1277 email: [email protected]
| Financial statements | |||
|---|---|---|---|
| SEK Thousands | January-Mars 2025 |
January-Mars 2024 |
January-December 2024 |
| Net sales | 218 588 | 186 022 | 822 415 |
| Cost of goods sold | -58 214 | -50 916 | -206 000 |
| Gross profit | 160 374 | 135 106 | 616 415 |
| Selling expenses Administrative expenses |
-73 710 -23 023 |
-64 584 -21 409 |
-283 982 -95 788 |
| Research and development expenses | -35 478 | -30 588 | -148 329 |
| Other operating income and expenses | -1 597 | 468 | 37 |
| Operating income | 26 566 | 18 993 | 88 353 |
| Financial income and expenses Income after financial items |
-40 617 -14 051 |
11 015 30 008 |
111 595 199 948 |
| Taxes | 1 652 | -7 223 | -27 766 |
| Net income | -12 399 | 22 785 | 172 182 |
| Attributable to Parent Company's shareholders |
-12 399 | 22 785 | 172 182 |
| Earnings per share, SEK | -0.39 | 0.72 | 5.47 |
| Earnings per share, SEK 1) | -0.39 | 0.72 | 5.44 |
| Average number of outstanding shares | 31 499 470 | 31 499 470 | 31 499 470 |
| Average number of outstanding shares 1) | 31 650 106 | 31 499 470 | 31 650 106 |
| Number of shares at closing day | 31 499 470 | 31 499 470 | 31 499 470 |
| Number of shares at closing day 1) | 31 650 106 | 31 499 470 | 31 650 106 |
| 42 967 | 35 942 | 176 069 | |
| EBITDA (Operating income before depreciation and amortization) | |||
| Depreciation and amortization on intangible assets | -7 796 | -9 313 | -55 273 |
| Depreciation and amortization on tangible assets | -8 605 | -7 636 | -32 443 |
| Operating income | 26 566 | 18 993 | 88 353 |
| 1) After dilution | |||
| January-Mars | January-Mars | January-December | |
| SEK Thousands Net income |
2025 -12 399 |
2024 22 785 |
2024 172 182 |
| Other comprehensive income | |||
| Items that may be reclassified to the income statement | |||
| Exchange rate differences | -52 671 | 34 770 | 31 303 |
| Earnings per share, SEK 1) | -0.39 | 0.72 | 5.44 |
|---|---|---|---|
| EBITDA (Operating income before depreciation and amortization) | |||
| 1) After dilution | |||
| January-Mars | January-Mars | January-December | |
| SEK Thousands | 2025 | 2024 | 2024 |
| Net income | -12 399 | 22 785 | 172 182 |
| Other comprehensive income | |||
| Items that may be reclassified to the income statement | |||
| Exchange rate differences | -52 671 | 34 770 | 31 303 |
| Total other comprehensive income | -52 671 | 34 770 | 31 303 |
| Total comprehensive income | -65 070 | 57 555 | 203 485 |
| Attributable to | |||
| Parent Company's shareholders | -65 070 | 57 555 | 203 485 |
| SEK Thousands | 250331 | 241231 | |
|---|---|---|---|
| ASSETS | |||
| Goodwill | 636 841 | 682 483 | |
| Capitalized development expenditure | 703 629 | 676 092 | |
| Other intangible assets | 43 735 | 48 704 | |
| Property, plant & equipment | 151 811 | 149 036 | |
| Financial assets | 32 646 | 33 352 | |
| Total non-current assets | 1 568 662 | 1 589 667 | |
| Inventories | 225 875 | 227 406 | |
| Current receivables | 184 670 | 170 149 | |
| Liquid funds | 315 871 | 415 521 | |
| Total current assets | 726 416 | 813 076 | |
| Total assets | 2 295 078 | 2 402 743 | |
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| Shareholders' equity, attributable to the Parent Company's shareholders | 2 092 401 | 2 156 778 | |
| Long-term interest-bearing liabilities | 20 285 | 23 126 | |
| Long-term non-interest-bearing liabilities | 42 763 | 45 329 | |
| Short-term interest-bearing liabilities | 9 023 | 10 917 | |
| Short-term non-interest-bearing liabilities | 130 606 | 166 593 | |
| Total shareholders' equity and liabilities | 2 295 078 | 2 402 743 | |
| January-March 2025 |
January-March 2024 |
January-December 2024 |
|
| Income after financial items | -14 051 | 30 008 | 199 948 |
| Adjustment for items not affecting cash flow | 61 963 | 8 620 | 741 |
| Paid taxes | -2 968 | -842 | -10 284 |
| Change in inventories | -6 230 | -3 895 | -77 515 |
| Change in trade receivables | -26 106 | -23 438 | -17 772 |
| Change in trade payables | -27 859 | -8 862 | 16 172 |
| Cash flow from operating activities | -15 251 | 1 591 | 111 290 |
| Cash flow from investing activities | -58 942 | -42 495 | -243 814 |
| Cash flow from financing activities | -2 997 | -2 368 | -10 902 |
| Income after financial items -14 051 30 008 199 948 Adjustment for items not affecting cash flow 61 963 8 620 741 Paid taxes -2 968 -842 -10 284 Change in inventories -6 230 -3 895 -77 515 Change in trade receivables -26 106 -23 438 -17 772 Change in trade payables -27 859 -8 862 16 172 Cash flow from operating activities -15 251 1 591 111 290 Cash flow from investing activities -58 942 -42 495 -243 814 Cash flow from financing activities -2 997 -2 368 -10 902 Cash flow for the period -77 190 -43 272 -143 426 Liquid funds at beginning of period 415 521 546 088 546 088 Exchange rate difference in liquid funds -22 460 8 337 12 859 Liquid funds at end of period 315 871 511 153 415 521 Attributable to Parent Company's shareholders Retained earnings incl. Sum Other paid in profit for the shareholders´ Share capital Reserves SEK Thousands capital year equity Shareholders´ equity as of January 1, 2024 805 1 763 782 60 884 119 574 1 945 045 Total comprehensive income January - March 2024 - - 34 770 22 785 57 555 |
|||
|---|---|---|---|
| Redovisningseffekt av incitamentsprogram enligt IFRS 2 - 506 - - 506 |
|||
| Shareholders´ equity as of March 31, 2024 805 1 764 288 95 654 142 359 2 003 106 |
|||
| Total comprehensive income April - December 2024 - - -3 467 149 397 145 930 |
|||
| Share warrant program - 7 742 - - 7 742 |
|||
| Shareholders´ equity as of December 31, 2024 805 1 772 030 92 187 291 756 2 156 778 Total comprehensive income January - March 2025 - - -52 671 -12 399 -65 070 |
|||
| Accounting effect of incentive programs according to IFRS 2 - 693 - - 693 |
|||
| Shareholders´ equity as of March 31, 2025 805 1 772 723 39 516 279 357 2 092 401 |
| Attributable to Parent Company's shareholders | |||||
|---|---|---|---|---|---|
| Other paid in | Retained earnings incl. profit for the |
Sum shareholders´ |
|||
| SEK Thousands | Share capital | capital | Reserves | year | equity |
| Shareholders´ equity as of January 1, 2024 | 805 | 1 763 782 | 60 884 | 119 574 | 1 945 045 |
| Total comprehensive income January - March 2024 | - | - | 34 770 | 22 785 | 57 555 |
| Redovisningseffekt av incitamentsprogram enligt IFRS 2 | - | 506 | - | - | 506 |
| Shareholders´ equity as of March 31, 2024 Total comprehensive income April - December 2024 |
805 - |
1 764 288 - |
95 654 -3 467 |
142 359 149 397 |
2 003 106 145 930 |
| Share warrant program | - | 7 742 | - | - | 7 742 |
| Shareholders´ equity as of December 31, 2024 | 805 | 1 772 030 | 92 187 | 291 756 | 2 156 778 |
| Total comprehensive income January - March 2025 | - | - | -52 671 | -12 399 | -65 070 |
| Accounting effect of incentive programs according to IFRS 2 Shareholders´ equity as of March 31, 2025 |
- 805 |
693 1 772 723 |
- 39 516 |
- 279 357 |
693 2 092 401 |
| Jan-Mar | Oct-Dec | Jul-Sep | Apr-Jun | Jan-Mar | Oct-Dec | Jul-Sep | Apr-Jun | |
|---|---|---|---|---|---|---|---|---|
| SEK Thousands | 2025 | 2024 | 2024 | 2024 | 2024 | 2023 | 2023 | 2023 |
| Net sales | 218 588 | 227 564 | 198 480 | 210 349 | 186 022 | 155 740 | 146 614 | 154 573 |
| Cost of goods sold | -58 214 | -52 430 | -50 549 | -52 105 | -50 916 | -38 506 | -39 016 | -39 111 |
| Gross profit | 160 374 | 175 134 | 147 931 | 158 244 | 135 106 | 117 234 | 107 598 | 115 462 |
| Selling expenses | -73 710 | -80 983 | -67 474 | -70 941 | -64 584 | -64 804 | -66 554 | -52 528 |
| Administrative expenses | -23 023 | -22 865 | -28 452 | -23 062 | -21 409 | -17 309 | -13 392 | -27 258 |
| Research and development costs | -35 478 | -55 808 | -30 863 | -31 070 | -30 588 | -51 014 | -27 126 | -31 629 |
| Other operating income and expenses | -1 597 | -16 | -670 | 255 | 468 | -231 | 4 776 | -245 |
| Operating income | 26 566 | 15 462 | 20 472 | 33 426 | 18 993 | -16 124 | 5 302 | 3 802 |
| Financial income and expenses | -40 617 | 34 154 | 67 207 | -781 | 11 015 | 81 686 | -4 348 | 7 638 |
| Income after financial items | -14 051 | 49 616 | 87 679 | 32 645 | 30 008 | 65 562 | 954 | 11 440 |
| Taxes | 1 652 | -13 229 | -1 862 | -5 452 | -7 223 | 2 912 | 1 330 | -4 554 |
| Net income | -12 399 | 36 387 | 85 817 | 27 193 | 22 785 | 68 474 | 2 284 | 6 886 |
| Attributable to | ||||||||
| Parent Company's shareholders | -12 399 | 36 387 | 85 817 | 27 193 | 22 785 | 68 474 | 2 284 | 6 886 |
| Earnings per share, SEK | -0.39 | 1.16 | 2.72 | 0.86 | 0.72 | 2.17 | 0.08 | 0.23 |
| Earnings per share, SEK 1) | -0.39 | 1.15 | 2.71 | 0.86 | 0.72 | 2.17 | 0.08 | 0.23 |
| Average number of outstanding shares | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 30 139 116 | 29 872 450 |
| Average number of outstanding shares 1) | 31 650 106 | 31 650 106 | 31 685 836 | 31 617 251 | 31 499 470 | 31 499 470 | 30 139 116 | 29 872 450 |
| Number of shares at closing day | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 31 499 470 | 29 899 470 |
| Number of shares at closing day 1) | 31 650 106 | 31 650 106 | 31 685 836 | 31 617 251 | 31 499 470 | 31 499 470 | 31 499 470 | 29 899 470 |
| EBITDA (Operating income before depreciation and | 42 967 | 51 884 | 37 099 | 51 144 | 35 942 | 20 746 | 18 931 | 17 216 |
| amortization) | ||||||||
| Depreciation and amortization on intangible assets | -7 796 | -27 605 | -8 732 | -9 623 | -9 313 | -30 025 | -7 725 | -7 715 |
| Depreciation and amortization on tangible assets | -8 605 | -8 817 | -7 895 | -8 095 | -7 636 | -6 845 | -5 904 | -5 699 |
| Operating income | 26 566 | 15 462 | 20 472 | 33 426 | 18 993 | -16 124 | 5 302 | 3 802 |
| 1) After dilution | ||||||||
| Jan-Mar | Oct-Dec | Jul-Sep | Apr-Jun | Jan-Mar | Oct-Dec | Jul-Sep | Apr-Jun | |
| SEK Thousands | 2025 | 2024 | 2024 | 2024 | 2024 | 2023 | 2023 | 2023 |
| Net income | -12 399 | 36 387 | 85 817 | 27 193 | 22 785 | 68 474 | 2 284 | 6 886 |
| Other comprehensive income | ||||||||
| Items that may be reclassified to the income statement: | ||||||||
| Exchange rate differences | -52 671 | 34 640 | -30 987 | -7 120 | 34 770 | -51 948 | -10 520 | 32 690 |
| Earnings per share, SEK 1) | -0.39 | 1.15 | 2.71 | 0.86 | 0.72 | 2.17 | 0.08 | 0.23 |
|---|---|---|---|---|---|---|---|---|
| EBITDA (Operating income before depreciation and | ||||||||
| Net income | -12 399 | 36 387 | 85 817 | 27 193 | 22 785 | 68 474 | 2 284 | 6 886 |
| Other comprehensive income | ||||||||
| Items that may be reclassified to the income statement: | ||||||||
| Exchange rate differences | -52 671 | 34 640 | -30 987 | -7 120 | 34 770 | -51 948 | -10 520 | 32 690 |
| Total other comprehensive income | -52 671 | 34 640 | -30 987 | -7 120 | 34 770 | -51 948 | -10 520 | 32 690 |
| Total comprehensive income | -65 070 | 71 027 | 54 830 | 20 073 | 57 555 | 16 526 | -8 236 | 39 576 |
| Attributable to |
| January-March | January-March | January-December | |
|---|---|---|---|
| SEK Thousands | 2025 | 2024 | 2024 |
| Gross margin, % | 73 | 73 | 75 |
| EBIT, % | 12 | 10 | 11 |
| EBIT (adjusted), % | 14 | 11 | 14 |
| EBITDA, % | 20 | 19 | 21 |
| EBITDA (adjusted), % | 21 | 20 | 22 |
| Net margin, % | -6 | 12 | 21 |
| Equity/assets ratio, % | 91 | 89 | 90 |
| Income per share, SEK | -0.39 | 0.72 | 5.47 |
| Shareholders' equity per share, SEK | 66.43 | 63.59 | 68.47 |
| Share price on closing day, SEK | 282 | 275 | 489 |
| Market cap on closing day, MSEK | 8 867 | 8 662 | 15 403 |
| January- | January- | January- | |
| SEK Thousands | March 2025 |
March 2024 |
December 2024 |
| Net sales | 108 222 | 99 293 | 453 072 |
| Cost of goods sold | -23 576 | -25 103 | -98 081 |
| Gross profit | 84 646 | 74 190 | 354 991 |
| Selling expenses | -20 039 | -21 734 | -84 074 |
| Administrative expenses | -23 313 | -21 376 | -100 459 |
| Research and development expenses | -20 485 | -19 976 | -105 605 |
| Other operating income and expenses | -1 265 | 824 | 5 058 |
| Operating income | 19 544 | 11 928 | 69 911 |
| Financial income and expenses | -36 928 | 13 028 | 53 526 |
| January- March |
January- March |
January- December |
|
|---|---|---|---|
| SEK Thousands | 2025 | 2024 | 2024 |
| Net sales | 108 222 | 99 293 | 453 072 |
| Cost of goods sold | -23 576 | -25 103 | -98 081 |
| Gross profit | 84 646 | 74 190 | 354 991 |
| Selling expenses | -20 039 | -21 734 | -84 074 |
| Administrative expenses | -23 313 | -21 376 | -100 459 |
| Research and development expenses | -20 485 | -19 976 | -105 605 |
| Other operating income and expenses | -1 265 | 824 | 5 058 |
| Operating income | 19 544 | 11 928 | 69 911 |
| Financial income and expenses | -36 928 | 13 028 | 53 526 |
| Income after financial items | -17 384 | 24 956 | 123 437 |
| -7 141 | -24 872 | ||
| Taxes Net income |
2 949 -14 435 |
17 815 | 98 565 |
| SEK Thousands | 250331 | 241231 | |
| ASSETS | |||
| Intangible assets | 581 068 | 554 548 | |
| Property, plant and equipment | 66 592 | 58 105 | |
| Financial assets | 917 132 | 904 218 | |
| Total non-current assets | 1 564 792 | 1 516 871 | |
| Inventories | 80 859 | 75 751 | |
| Current receivables | 65 171 | 62 811 | |
| Cash and bank | 182 872 | 270 882 |
| SEK Thousands | 250331 | 241231 |
|---|---|---|
| ASSETS | ||
| Intangible assets | 581 068 | 554 548 |
| Property, plant and equipment | 66 592 | 58 105 |
| Financial assets | 917 132 | 904 218 |
| Total non-current assets | 1 564 792 | 1 516 871 |
| Inventories | 80 859 | 75 751 |
| Current receivables | 65 171 | 62 811 |
| Cash and bank | 182 872 | 270 882 |
| Total current assets | 328 902 | 409 444 |
| Total assets | 1 893 694 | 1 926 315 |
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||
| Shareholders' equity | 1 814 818 | 1 828 078 |
| Provisions | 2 862 | 3 014 |
| Provisions Short-term non-interest-bearing liabilities |
12 698 63 316 |
12 698 82 525 |
TSEK 250331 241231 Opening balance 5 448 64 415 Revaluation of additional purchase considerations -478 -58 967
| TSEK | 250331 | 241231 |
|---|---|---|
| Opening balance | 5 448 | 64 415 |
| Revaluation of additional purchase considerations | -478 | -58 967 |
| Closing balance | 4 970 | 5 448 |
| Closing balance | 4 970 | 5 448 | ||||||
|---|---|---|---|---|---|---|---|---|
| Thoracic | Abdominal | January-March | Services | Total consolidated | ||||
| SEK Thousands | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 |
| Lung | 133 810 | 109 178 | - | - | - | - | 133 810 | 109 178 |
| Heart | 7 888 | 11 708 | - | - | - | - | 7 888 | 11 708 |
| Liver | - | - | 42 655 | 33 362 | - | - | 42 655 | 33 362 |
| Kidney | - | - | 13 905 | 10 636 | - | - | 13 905 | 10 636 |
| Service | - | - | - | - | 20 330 | 21 138 | 20 330 | 21 138 |
| Net sales | 141 698 | 120 886 | 56 560 | 43 998 | 20 330 | 21 138 | 218 588 | 186 022 |
| January-March | ||||||||
| Abdominal | 2024 | Services 2025 |
Total consolidated | |||||
| Thoracic | 2024 | 2025 | 2024 | |||||
| SEK Thousands | 2025 | 2024 | 2025 | |||||
| USA | 87 874 | 74 113 | 6 933 | 6 120 | 20 330 | 21 138 | 115 137 | 101 371 |
| Americas, excl USA EMEA |
5 280 38 247 |
8 378 30 641 |
206 48 198 |
- 36 265 |
- - |
- - |
5 486 86 445 |
8 378 66 906 |
| APAC | 10 297 | 7 754 | 1 223 | 1 613 | - | - | 11 520 | 9 367 |
| January-March | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Thoracic | Abdominal | Services | Total consolidated | |||||||
| SEK Thousands | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | ||
| USA | 87 874 | 74 113 | 6 933 | 6 120 | 20 330 | 21 138 | 115 137 | 101 371 | ||
| Americas, excl USA | 5 280 | 8 378 | 206 | 5 486 | 8 378 | |||||
| EMEA | 38 247 | 30 641 | 48 198 | 36 265 | 86 445 | 66 906 | ||||
| APAC | 10 297 | 7 754 | 1 223 | 1 613 | - | 11 520 | 9 367 | |||
| Not onloa | 000 NY W | 490 000 | CC CCO | 42 000 | 20 220 | 94 420 | 940 COO | 100 000 |
| January-March | Total consolidated | |||||||
|---|---|---|---|---|---|---|---|---|
| Thoracic | Abdominal | Services | ||||||
| SEK Thousands Net sales |
2025 141 698 |
2024 120 886 |
2025 56 560 |
2024 43 998 |
2025 20 330 |
2024 21 138 |
2025 218 588 |
2024 186 022 |
| Cost of goods sold | -24 840 | -23 083 | -20 685 | -14 310 | -12 689 | -13 523 | -58 214 | -50 916 |
| Gross profit | 116 858 | 97 803 | 35 875 | 29 688 | 7 641 | 7 615 | 160 374 | 135 106 |
| Gross margin (%) | 82 | 81 | 63 | 67 | 38 | 36 | 73 | 73 |
| TSEK | January-March 2025 |
January-March | 2024 | January-December 2024 |
||||
| Opening balance | 682 483 | 591 392 | 591 392 | |||||
| Acquired goodwill | - | - | 56 630 | |||||
| Exchange-rate differences Closing balance |
-45 642 636 841 |
26 533 617 925 |
34 461 682 483 |
| Acquired goodwill | - | - | 56 630 |
|---|---|---|---|
| January- March |
January- | ||
|---|---|---|---|
| EBITDA (Operating income before depreciation and amortization) |
42 967 | 35 942 | 176 069 |
| measures | |||
|---|---|---|---|
| January- | January- | January- | |
| March | March | December | |
| EBITDA (Operating income before depreciation and | |||
| amortization) | 42 967 | 35 942 | 176 069 |
| January- | January- | January- | |
| March | March | December | |
| SEK Thousands | 2025 | 2024 | 2024 |
| EBITDA (Operating income before depreciation and amortization) |
42 967 | 35 942 | 176 069 |
| Acquisition costs | 300 | - | 5 559 |
| Integration costs | 2 901 | 944 | 1 430 |
| EBITDA (adjusted) | 46 168 | 36 886 | 183 058 |
| January- | January- | January- | |
| March | March | December | |
| SEK Thousands | 2025 | 2024 | 2024 |
| EBIT (Operating income ) | 26 566 | 18 993 | 88 353 |
| Acquisition costs | 300 | - | 5 559 |
| Integration costs | 2 901 | 944 | 1 430 |
| Write-down of intangible asset | - | - | 20 291 |
| EBIT (adjusted) | 29 767 | 19 937 | 115 633 |
| January- | January- | ||
| March | December | ||
| SEK Thousands | 2025 | 2024 | 2024 |
| January- | |
|---|---|
| EBITDA (Operating income before depreciation and | |||
|---|---|---|---|
| January- | |||
| EBITDA (Operating income before depreciation and | |||
| January- | January- | January- | |
| March | March | December | |
| Write-down of intangible asset | - | - | 20 291 |
| EBIT (adjusted) | 29 767 | 19 937 | 115 633 |
| January- | January- | January- | |
| SEK Thousands | March 2025 |
March 2024 |
December 2024 |
| Operating income | |||
| Net sales | 218 588 | 186 022 | 822 415 |
| Operating expenses | |||
| Cost of goods sold | -58 214 | -50 916 | -206 000 |
| Gross profit | 160 374 | 135 106 | 616 415 |
| Gross margin % | 73 | 73 | 75 |
| SEK Thousands | 250331 | 241231 | |
| Shareholders' equity | 2 092 401 | 2 156 778 | |
| Total assets | 2 295 078 | 2 402 743 | |
| Equity/assets ratio % | 91 | 90 | |
| SEK Thousands | 250331 | 241231 |
|---|---|---|
| Key ratios | Definition | Purpose |
|---|---|---|
| Gross margin, % | Gross profit for the period divided by net sales for the period. |
I he company believes that the key ratio provides an in-depth understanding of the company's profitability. |
| EBITDA margin, % | EBITDA (operating income before depreciation and amortization for the period) divided by net sales for the period. |
The company believes that the key ratio provides an in-depth understanding of the company's profitability. |
| Adjusted EBITDA margin,% | EBITDA (operating income before depreciation and amortization for the period) adjusted for items affecting comparability and divided by net sales for the period. |
The company believes that the key ratio provides an in-depth understanding of the company's profitability. The company also considers that adjusted EBITDA provides a more true and fair view of the company's EBITDA for the core operations. |
| Adjusted EBIT margin,% | EBIT (operating income for the period) adjusted for items affecting comparability, divided by net sales for the period. |
The company believes that the metric provides an in-depth understanding of the company's profitability. The company also considers that adjusted EBIT provides a more true and fair view of the company's EBIT for the core operations. |
| Operating margin, % | Operating income for the period divided by net sales for the period. |
I he company believes that the key ratio provides an in-depth understanding of the company's profitability. |
| Net margin, % | Operating income for the period divided by net sales for the period. |
The company believes that the key ratio provides an in-depth understanding of the company's profitability. |
| Equity/assets ratio, % | Shareholders' equity divided by total assets. | The ratio indicates what percentage of total assets consists of shareholders' equity and it has been included to help provide investors with an in depth understanding of the company's capital structure. |
| Shareholders' equity per share, SEK | Shareholders' equity in relation to the number of shares outstanding on the balance sheet date. |
The key ratio has been included to give investors an overview of how the company's equity per share has evolved. |
| Earnings per share, SEK | Income for the period divided by the average number of shares before dilution for the period. |
The key ratio has been included to give investors an overview of how the company's earnings per share have evolved. |
| Earnings per share after dilution, SEK |
Income for the period divided by the average number of shares after dilution for the period. |
The key ratio has been included to give investors an overview of how the company's earnings per share after dilution have evolved. |
| Organic growth | Organic growth refers to sales growth compared to the same period the previous year, adjusted for currency translation effects and acquisitions. Acquisitions are adjusted for by excluding net sales during the current year for acquisitions made during the current or previous year where the net sales relate to the period when the acquisition did not contribute to sales in both years. Currency effects are calculated by recalculating the period's and previous period's sales in local currencies in SEK at the same exchange rate. |
Organic growth enables comparison of net sales over time, excluding the impact of currency translation effects and acquisitions. |
The following explanations are intended to help the reader understand certain specific terms and expressions in XVIVO's reports:
| DBD | Donation after brain death. |
|---|---|
| DCD | Donation after circulatory death. |
| DHOPE | Double hypothermic non-ischemic machine organ perfusion, i.e. cold oxygenated machine organ perfusion using double cannulation |
| Assessment | Assessment of the function of an organ. |
| Ex vivo (Latin for "outside a living organism") |
Biological processes in living cells and tissues when they are in an artificial environment outside the body. The opposite of in vivo. |
| EVLP (Ex Vivo Lung Perfusion) Perfusion of a lung outside is normally carried out to assess a lung before transplantation. | |
| FDA or US Food and Drug Administration |
The FDA is the US tood and drug authority with responsibility for food, dietary supplements, drugs, cosmetics, medical equipment, radiology equipment, and blood products. FDA approval is required to market a medical device on the US market. |
| HDE or Humanitarian Device Exemption |
A humanitarian device exemption (HDE) application can be submitted to the FDA for a medical device that is intended to benefit patients by treating or disease or condition that affects or is manifested in fewer than 8,000 individuals in the US per year. A HDE is similar in both form and content to a Premarket Approval (PMA) application but is exempt from the efficacy requirements of a PMA. |
| HOPE | Hypothermic non-ischemic machine organ perfusion, i.e. cold oxygenated machine organ perfusion |
| IDE-application | An Investigational Device Exemption (IDE) is an application that must be submitted to receive the Food and Drug Administration's (FDA) approval to use a novel medical device in a clinical study. |
| Clinical study/trial | A study in healthy or sick people to examine the effect of a drug or treatment method. |
| Machine perfusion | New technology that improves preservation and assessment of organs, which means more organs can be used for transplants. In the Thoracic business area, this includes STEEN Solution™, XPS™, Lung Assist and Heart Assist as well as other products and services related to the use of those machines. In the Abdominal business area, this includes Kidney Assist Transport, Kidney Assist as well as other products and services related to the use of those machines. |
| NRP | Normothermic regional perfusion. Treatment method in DCD donation where organs are perfused in the donor. |
| OPO or Organ Procurement Organization |
In the US, an organ procurement organization (OPO) is a non-profit organization responsible for the assessment and procurement of deceased-donor organ transplantation. There are approximately 58 such organizations in the US. |
| Perfusion | Passage of a fluid through an organ's blood vessels. |
| PMA or Premarket Approval efficacy of a medical device. |
|
| Pre-clinical study | Research performed before a drug or method of treatment is sufficiently documented to be studied in humans. |
| Preservation | Storage and maintenance of an organ outside the body before transplantation. |
| Reimbursement | Reimbursement is used in the health insurance system to enable healthcare providers to be reimbursed faster and more easily for accrued expenses from a private or public insurance company (in the US, e.g. Medicare), |
| Static preservation | Static preservation refers to preservation methods where the organ is cooled during transport and before transplantation. In the Thoracic business area, this includes Perfadex® Plus as well as other products and services related to the use of that product. |
| Xenotransplantation | Transplantation of cells, tissues or organs from one species to another. |
| Other sales | The Other sales product category refers to revenues relating to freight, service and training, |

Gemenskapens gata 9 SE-431 51 Mölndal Sweden Corp. ID No. 556561-0424
[email protected] www.xvivogroup.com
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