Annuncio • Jun 10
OssDsign AB (publ) Elects Per Aniansson as Board Member and Chairman OssDsign AB (publ) at its annual general meeting held on June 9, 2026 approved Per Aniansson as new ordinary board member, and to elect Per Aniansson as new chairman of the board. Breakeven Date Change • May 20
No longer forecast to breakeven The 3 analysts covering OssDsign no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr18.2m in 2028. New consensus forecast suggests the company will make a loss of kr13.6m in 2028. Annuncio • May 12
OssDsign AB (publ), Annual General Meeting, Jun 09, 2026 OssDsign AB (publ), Annual General Meeting, Jun 09, 2026, at 10:00 W. Europe Standard Time. Location: setterwalls advokatbyras premises, sturegatan 10, stockholm Sweden Annuncio • Apr 10
OssDsign AB (publ) to Report Q1, 2026 Results on May 05, 2026 OssDsign AB (publ) announced that they will report Q1, 2026 results on May 05, 2026 Annuncio • Jun 30
An undisclosed buyer completed the acquisition of an unknown minority stake in OssDsign AB (publ) (OM:OSSD) from Karolinska Development AB (publ) (OM:KDEV). An undisclosed buyer acquired an unknown minority stake in OssDsign AB (publ) (OM:OSSD) from Karolinska Development AB (publ) (OM:KDEV) on June 30, 2025.
An undisclosed buyer completed the acquisition of an unknown minority stake in OssDsign AB (publ) (OM:OSSD) from Karolinska Development AB (publ) (OM:KDEV) on June 30, 2025. Annuncio • Jun 27
OssDsign AB (publ.) Announces remarkable Real-World Results with 88.4% Fusion Rate in a Highly Complex Patient Cohort from the Spinal Fusion Registry PROPEL OssDsign AB (publ.) announced that the company has published one-year results from the first 108 patients in its prospective, multi-center, spinal fusion registry PROPEL. The results show an outstanding fusion rate of 88.4% in the real-world setting in a highly complex patient cohort, demonstrating that OssDsign Catalyst®? shows strong performance even in challenging patient populations with high BMI, previous failed fusion surgeries, smokers, multi-level procedures and several comorbidities. The results are based on 108 patients and the studied population is considered a highly complex patient cohort with the following profile: Average BMI of 31.9 (obese); 93.6% of patients had at least one comorbidity with 48% having three or more comorbidities; 50% had previous spine fusion surgery performed; 48.0% were active or previous smokers; 20.3% of all procedures involved three or more levels of the spine. At the 12-month follow-up, all patients showed improvement in each health status category assessed, with no unexpected device-related adverse events and a successful fusion rate of 88.4%, and between 84.7% and 93.4% in high-risk subgroups. PROPEL is a prospective spinal fusion registry that aims to bridge the gap between the device's performance in a controlled clinical trial and its use in everyday clinical practice over time. To date, over 300 patients are enrolled. 108 patients were included in this analysis across six sites; surgery dates ranged from April 25, 2022, to August 21, 2023. Any patient aged 21 years or older, requiring spinal fusion surgery for which OssDsign Catalyst was being used, was considered appropriate for inclusion if, in the investigator's opinion, the patient could comply with the registry protocol requirements. The primary endpoint was the fusion (bridging bone) assessment at 12 months +- 60 days post-surgery. Clinical outcomes were assessed as secondary endpoints, with success defined as any improvement from baseline scores for the following: Quality of Life Questionnaires (VAS and ODI/NDI, as applicable, and SF-36) and the maintenance or improvement of neurological function. A safety review was also conducted for all Adverse Events (AEs). Annuncio • Jun 11
OssDsign AB (publ) Approves Board Changes OssDsign AB (publ) approved election of David Jern and Tomas Blomquist as new ordinary board members. Annuncio • Jun 10
Newton Aguiar Declines Re-Election as Director of OssDsign AB (Publ) OssDsign AB (publ) announced that Newton Aguiar has declined re-election as director. Annuncio • May 14
OssDsign AB (publ) to Report Fiscal Year 2025 Results on Feb 03, 2026 OssDsign AB (publ) announced that they will report fiscal year 2025 results on Feb 03, 2026 Annuncio • May 13
OssDsign AB (publ), Annual General Meeting, Jun 11, 2025 OssDsign AB (publ), Annual General Meeting, Jun 11, 2025, at 13:00 W. Europe Standard Time. Location: at setterwalls advokatbyras, offices at address sturegatan 10, stockholm Sweden Annuncio • May 07
OssDsign AB (publ) to Report Q1, 2025 Results on May 06, 2025 OssDsign AB (publ) announced that they will report Q1, 2025 results on May 06, 2025 Annuncio • May 02
OssDsign AB (publ) Announces Morten Henneveld Stepping Down as Chief Executive Officer OssDsign AB (publ) announced that Morten Henneveld will step down as CEO at the end of the year to support the establishment of leadership with an even stronger presence and focus on the US market. The board will begin the process of recruiting a new CEO to lead the company's continued expansion in the United States. Since the launch of OssDsign Catalyst in the U.S. in August 2021, and the following the strategic shift to become a pure play orthobiologics company, OssDsign has shown high double-digit growth. To lead the continued rapid growth and expansion in the United States, the Board and CEO Morten Henneveld have agreed this is best achieved by leadership with an even stronger presence and focus on this key market. The Board will therefore begin an orderly transition to a new CEO. Reported Earnings • Nov 13
Third quarter 2024 earnings released: kr0.10 loss per share (vs kr0.50 loss in 3Q 2023) Third quarter 2024 results: kr0.10 loss per share (improved from kr0.50 loss in 3Q 2023). Revenue: kr35.7m (up 13% from 3Q 2023). Net loss: kr9.76m (loss narrowed 71% from 3Q 2023). Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 6.0% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 12% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 21
Second quarter 2024 earnings released: kr0.20 loss per share (vs kr0.30 loss in 2Q 2023) Second quarter 2024 results: kr0.20 loss per share (improved from kr0.30 loss in 2Q 2023). Revenue: kr29.7m (up 24% from 2Q 2023). Net loss: kr15.7m (loss narrowed 23% from 2Q 2023). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 6.5% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Annuncio • Jun 25
OssDsign AB (publ) Approves Election of Christer Fåhraeus as Ordinary Board Member OssDsign AB (publ) announced at the AGM held on June 25, 2024, approved election of Christer Fåhraeus as ordinary board member. Annuncio • May 17
OssDsign AB (publ) to Report Fiscal Year 2023 Final Results on Jun 04, 2024 OssDsign AB (publ) announced that they will report fiscal year 2023 final results on Jun 04, 2024 Reported Earnings • May 15
First quarter 2024 earnings released: kr0.10 loss per share (vs kr0.30 loss in 1Q 2023) First quarter 2024 results: kr0.10 loss per share (improved from kr0.30 loss in 1Q 2023). Revenue: kr27.0m (up 26% from 1Q 2023). Net loss: kr11.1m (loss narrowed 52% from 1Q 2023). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 6.9% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. Annuncio • May 15
OssDsign AB (publ) to Report Fiscal Year 2024 Results on Feb 04, 2025 OssDsign AB (publ) announced that they will report fiscal year 2024 results on Feb 04, 2025 Breakeven Date Change • Apr 17
No longer forecast to breakeven The 5 analysts covering OssDsign no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr2.72m in 2025. New consensus forecast suggests the company will make a loss of kr2.93m in 2025. Annuncio • Feb 29
OssDsign AB (publ.) Appoints Tom Buckland as Chief Technical Officer OssDsign AB (publ.) announced that the company's current VP of Strategy, Business Development and Regulatory Affairs, Tom Buckland, has been appointed Chief Technical Officer (CTO). The promotion is a key part of the company's change of direction into a pure-play orthobiologics company focusing exclusively on the U.S. Market. Tom Buckland, currently VP of Strategy, Business Development and Regulatory Affairs, will in his new role be responsible for Operations & Manufacturing, Research & Development as well as Quality Assurance and Regulatory Affairs. Tom Buckland joined OssDsign through the acquisition of Sirakoss, where he was the CEO. His previous experiences include leading positions at Nuvasive, Apatech and Baxter as well as working as a reputable advisor to start- and scale-up companies. Tom Buckland holds a Masters' degree in Mechanical Engineering and a Ph.D. in Biomaterials from the University of London. Breakeven Date Change • Feb 07
Forecast breakeven date moved forward to 2024 The 3 analysts covering OssDsign previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of kr12.0m in 2024. Earnings growth of 78% is required to achieve expected profit on schedule. Reported Earnings • Feb 07
Full year 2023 earnings released: kr1.60 loss per share (vs kr1.70 loss in FY 2022) Full year 2023 results: kr1.60 loss per share. Revenue: kr112.2m (up 97% from FY 2022). Net loss: kr130.5m (loss widened 31% from FY 2022). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 6.5% growth forecast for the Medical Equipment industry in Germany. Annuncio • Feb 06
OssDsign AB (publ), Annual General Meeting, May 21, 2024 OssDsign AB (publ), Annual General Meeting, May 21, 2024. Breakeven Date Change • Jan 25
Forecast breakeven date moved forward to 2024 The 3 analysts covering OssDsign previously expected the company to break even in 2025. New consensus forecast suggests the company will make a profit of kr12.0m in 2024. Average annual earnings growth of 116% is required to achieve expected profit on schedule. Annuncio • Jan 24
OssDsign AB (publ.) Announces 12-Month Data from the Clinical Study Top Fusion OssDsign AB (publ.) announced that the previously communicated outstanding 12-month results from the clinical study TOP FUSION have been published in the peer-reviewed journal Biomedical Journal of Scientific & Technical Research. The results show a 93 % spinal fusion rate as well as improvements in quality of life and pain following surgery with the novel nanosynthetic bone graft OssDsign Catalyst. The data, published in the peer-reviewed Journal of Scientific & Technical Research, clearly demonstrates that the use of OssDsign Catalyst leads to consistent and rapid bone healing and remodeling, with improved patient outcomes as a result. High fusion rate and improved quality of life. The use of synthetic bone graft substitutes has become more common to avoid the need to source allograft oriliac crest autograft. A new nanosynthetic, silicate-enriched calcium phosphate bone graft substitute, OssDsign Catalyst, has been designed to deliver consistent and rapid bone healing and renovation. The high level ofuted silicate (5.8%) in the porous granules combined with the nanoscale architecture is thought to promote early bone formation. TOP FUSION includes 17 patients suffering from degenerative disc disease, degenerative spondylolisthesis, or lumbar spinal stenosis to evaluate the safety and efficacy of OssDsign Catalyst in patients undergoing spinal Transforaminal Lumbar Interbody Fusion (TLIF) surgery. Post-operative follow-up took place at 6 weeks, 3 months, 6 months and 12 months post-operatively to assess the presence of fusion. CTs were independently radiologically reviewed by Medical Metrics Inc. Of the 17 patients recruited in TOP FUSION, three were withdrawn for reasons unrelated to Catalyst. All the remaining 14 patients completed the follow-up 12 months after surgery. The post-operative follow-ups showed that 4/14 (29%) of the patients were fused at 3 months, 9/14 (64%) at 6 months, and 13/14 (93%) at 12 months. The remaining patient has evidence of fusion progression so may be fused at the 24-month follow-up visit. All scores used to quantify pain and function including Oswestry Disability Index (ODI), visual analog scale (VAS) and overall health in patients (SF-36) showed improvement in quality of life over time, at all post-operative follow-up evaluations. No device-related Adverse Events (AEs) were observed during the study. OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. The graft is composed of a proprietary nanocrystalline structure which is resorbed and replaced by new and healthy bone tissue in the body. The clinical study TOP FUSION (NCT05114135) is a first-in-patient open-label, prospective, single-center clinical study led by Dr. Péter Pál Varga and Dr. Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary. The study's primary endpoint is assessed by the rate of bone fusion at 12 months by CT as well as the lack of device-related adverse events within the study period. TOP FUSION is a two-year study, and a final follow-up will be made at 24 months. Annuncio • Jan 09
OssDsign AB (publ) Reports Exceptional Data from the Clinical Study TOP FUSION OssDsign AB (publ) announced that positive data from the clinical study TOP FUSION has been submitted to a peer-reviewed scientific journal. Top-line results show a 93 % spinal fusion rate at 12 months as assessed with CT by independent radiological review from Medical Metrics Inc. after surgery with the novel nanosynthetic bone graft OssDsign Catalyst. The data indicates that the use of OssDsign Catalyst leads to consistent and rapid bone healing and remodeling, with improved patient outcomes as a result. They also confirm the previously reported best-in-class pre-clinical results achieved in the most demanding preclinical model for spinal fusion - the BODEN model. TOP FUSION is a first-in-patient open-label, prospective, single-center clinical study led by Dr Péter Pál Varga and Dr Àron Lazary at the National Center for Spinal Disorders at the Buda Health Clinic in Budapest, Hungary. Annuncio • Dec 06
Ossdsign AB (Publ) Provides Revenue Guidance for the Fourth Quarter of 2023 OssDsign AB (publ) provided revenue guidance for the fourth quarter of 2023. For the quarter, company expected its revenues to exceed market expectations. Annuncio • Dec 02
An Unknown buyer acquired 7.6% stake in OssDsign AB (publ) (OM:OSSD). An Unknown buyer acquired 7.6% stake in OssDsign AB (publ) (OM:OSSD) on November 30, 2023.An Unknown buyer completed the acquisition of 7.6% stake in OssDsign AB (publ) (OM:OSSD) on November 30, 2023. Annuncio • Nov 21
OssDsign AB (publ) to Report Fiscal Year 2023 Results on Feb 06, 2024 OssDsign AB (publ) announced that they will report fiscal year 2023 results on Feb 06, 2024 Annuncio • Sep 29
OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 150.000003 million. OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 150.000003 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 17,835,782
Price\Range: SEK 5.7
Security Name: Shares
Security Type: Common Stock
Securities Offered: 8,480,008
Price\Range: SEK 5.7
Transaction Features: Subsequent Direct Listing Annuncio • Sep 27
OssDsign AB (publ) Announces All Activities Pertaining to the Patient-Specific Cranial Implant Business Will Be Discontinued in A Responsible Manner by the End of December 2023 OssDsign AB (publ) announced a strategic shift to focus its operations on the orthobiologics business in the U.S, in order to increase shareholder value. The new strategy means that OssDsign will become a pure play orthobiologics company focusing on the nanosynthetic bone graft OssDsign Catalyst, an off-the-shelf product characterized by high scalability and high gross margins at 90% or above. All activities pertaining to the company's patient-specific cranial implant business will be discontinued in a responsible manner by the end of December 2023, resulting in a substantial cost base reduction going forward. As a result, the future capital requirement ahead of becoming cash flow positive will be significantly decreased. Based on the revised strategy, OssDsign's financial target is to reach sales of SEK 150-200 million in the medium-term, at which point the company also expects to become cash flow positive. The strategic shift announced now will potentially affect approximately 25 positions in the company and is expected to reduce annual operating expenditures by approximately SEK 30-40 million, leading to an approx. 30% improvement in cash flow. One-off restructuring costs are estimated to have a SEK 10-15 million negative cash impact. In addition, there will be other, non-cash, restructuring costs related to the discontinuation of the cranial implant business. Annuncio • Sep 19
OssDsign Receives FDA Clearance for A New Major Indication Karolinska Development AB announced that its portfolio company OssDsign has received clearance from FDA for the use of OssDsign Catalyst in interbody cages in spinal surgery. The FDA clearance creates possibilities in a new indication with major market potential for the company's innovative nanosynthetic bone graft. The clearance from the U.S. Food and Drug Administration (FDA) allows surgeons to use the OssDsign Catalyst on-label in any interbody cage cleared for use with synthetic bone grafts. OssDsign Catalyst is the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone. The decision by the FDA is based on OssDsign's outstanding bone regeneration results which surpass other synthetic bone grafts in challenging evaluation models. Buying Opportunity • Sep 05
Now 22% undervalued Over the last 90 days, the stock is up 1.0%. The fair value is estimated to be €0.52, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 46% over the last 3 years. Earnings per share has grown by 50%. Revenue is forecast to grow by 67% in a year. Earnings is forecast to grow by 50% in the next year. Reported Earnings • Aug 23
Second quarter 2023 earnings released: kr0.30 loss per share (vs kr0.40 loss in 2Q 2022) Second quarter 2023 results: kr0.30 loss per share (improved from kr0.40 loss in 2Q 2022). Revenue: kr25.5m (up 104% from 2Q 2022). Net loss: kr20.3m (loss narrowed 15% from 2Q 2022). Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 6.3% growth forecast for the Medical Equipment industry in Germany. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. Breakeven Date Change • May 24
Forecast breakeven date moved forward to 2024 The 3 analysts covering OssDsign previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 22% to 2023. The company is expected to make a profit of kr14.0m in 2024. Average annual earnings growth of 94% is required to achieve expected profit on schedule. Reported Earnings • Apr 30
Full year 2022 earnings released: kr1.70 loss per share (vs kr1.94 loss in FY 2021) Full year 2022 results: kr1.70 loss per share. Revenue: kr72.7m (up 129% from FY 2021). Net loss: kr99.4m (loss widened 5.8% from FY 2021). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 6.5% growth forecast for the Medical Equipment industry in Germany. Breakeven Date Change • Mar 15
No longer forecast to breakeven The 3 analysts covering OssDsign no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr49.5m in 2025. New consensus forecast suggests the company will make a loss of kr91.0m in 2025. Reported Earnings • Feb 22
Full year 2022 earnings released: kr1.70 loss per share (vs kr1.94 loss in FY 2021) Full year 2022 results: kr1.70 loss per share. Revenue: kr57.0m (up 80% from FY 2021). Net loss: kr99.4m (loss widened 5.8% from FY 2021). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 6.2% growth forecast for the Medical Equipment industry in Germany. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 3 analysts covering OssDsign expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr49.2m in 2025. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Annuncio • Dec 01
OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 65.63568 million. OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 65.63568 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 14,268,626
Price\Range: SEK 4.6
Transaction Features: Subsequent Direct Listing Reported Earnings • Nov 23
Third quarter 2022 earnings released: kr0.30 loss per share (vs kr0.30 loss in 3Q 2021) Third quarter 2022 results: kr0.30 loss per share (in line with 3Q 2021). Revenue: kr22.5m (up 152% from 3Q 2021). Net loss: kr19.6m (loss widened 18% from 3Q 2021). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 6.2% growth forecast for the Medical Equipment industry in Germany. Reported Earnings • Aug 24
Second quarter 2022 earnings released: kr0.40 loss per share (vs kr0.40 loss in 2Q 2021) Second quarter 2022 results: kr0.40 loss per share (vs kr0.40 loss in 2Q 2021). Revenue: kr16.5m (up 116% from 2Q 2021). Net loss: kr23.9m (loss narrowed 5.5% from 2Q 2021). Over the next year, revenue is forecast to grow 85%, compared to a 7.7% growth forecast for the Medical Equipment industry in Germany. Annuncio • Aug 18
OssDsign AB (publ) Ordinary Shares to Be Deleted from OTC Equity OssDsign AB (publ) Ordinary Shares will be deleted from OTC Equity effective from August 18, 2022, due to Inactive Security. Board Change • Jul 31
High number of new directors Director Jill Schiaparelli was the last director to join the board, commencing their role in 2022. Annuncio • Jun 02
OssDsign AB (publ) Elects Jill Shiaparelli as Board Member OssDsign AB (publ) announced that at its AGM held on June 1, 2022, the shareholders elected Jill Shiaparelli as ordinary board member. Reported Earnings • May 25
First quarter 2022 earnings released: kr0.40 loss per share (vs kr1.10 loss in 1Q 2021) First quarter 2022 results: kr0.40 loss per share. Revenue: kr8.88m (up 48% from 1Q 2021). Net loss: kr24.0m (loss widened 2.7% from 1Q 2021). Over the next year, revenue is forecast to grow 111%, compared to a 7.2% growth forecast for the industry in Germany. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Director Newton Aguiar was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Feb 24
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: kr1.90 loss per share (up from kr4.44 loss in FY 2020). Revenue: kr35.7m (up 43% from FY 2020). Net loss: kr93.9m (loss widened 11% from FY 2020). Revenue exceeded analyst estimates by 1.0%. Over the next year, revenue is forecast to grow 76%, compared to a 11% growth forecast for the industry in Germany. Annuncio • Feb 22
OssDsign AB (publ), Annual General Meeting, Jun 02, 2022 OssDsign AB (publ), Annual General Meeting, Jun 02, 2022. Board Change • Feb 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Director Newton Aguiar was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Jan 14
OssDsign AB (publ.) Receives Approval to Establish Clinical Registry in the U.S. to Collect Real-World Data on OssDsign Catalyst OssDsign AB (publ.) announced that the Western Institutional Review Board (WIRB), one of the largest institutional research review organizations in the U.S., has approved the company's application to establish PROPEL, a multi-centre, prospective spinal fusion registry, providing opportunity to study real-world data from patients who have been treated with OssDsign Catalyst. OssDsign Catalyst received FDA clearance in 2020 and was launched in the U.S. in August 2021. During 2022, clinics will gradually be enrolled to the registry, with the objective to evaluate the use and outcome of OssDsign Catalyst in a real-world clinical practice. The primary endpoint of the study will be measuring the rate of spinal fusion, using computer tomography (CT) or radiography, 12 months postoperatively. Additionally, patients' quality of life and neurological function, as well as the clinical safety profile of the spinal implant will be recorded. PROPEL will play an important role in bridging the gap between the device performance in clinical trials and their use in routine practice over time. The registry is the latest step in OssDsign's strategy to collect clinical evidence of its synthetic bone graft OssDsign Catalyst. Concurrently, the company's clinical study TOP FUSION, evaluating the long-term safety and efficacy of OssDsign Catalyst in patients, is continuing to enroll subjects in Hungary. Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 3 analysts covering OssDsign expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr4.70m in 2024. Average annual earnings growth of 57% is required to achieve expected profit on schedule. Annuncio • Dec 05
OssDesign AB (Publ.) Announces Updated Clinical Data from A Long-Term Follow-Up of the Company's Innovative Product OssDsign Cranial PSI, Which Is Used in the Treatment of Cranial Bone Defects OssDsign AB (publ.) announced updated clinical data from a long-term follow-up of the company's innovative product OssDsign Cranial PSI, which is used in the treatment of cranial bone defects. The data, based on 1,480 surgeries, shows that the frequency of infections leading to implant removal was 1.6% after a median follow-up time of 22 months. This positive outcome exceeds what has been observed in previous follow-ups, thus highlighting the exceptional performance of OssDsign Cranial PSI. OssDsign Cranial PSI is a patient-specific cranial implant made from 3D printed medical-grade titanium covered by a regenerative calcium phosphate composition. While the titanium skeleton reinforces the implant and resists physical and mechanical stress, the unique calcium phosphate composition provides healing and regenerative properties, allowing regrowth of the patient's own bone. Over time, the calcium phosphate composition degrades and is replaced with bone, leaving the patient with a well-integrated implant, potentially lasting a lifetime. The results of the long-term follow-up show that complications in the form of infections leading to explanation of OssDsign Cranial PSI occurred in 1.6% of 1,480 surgeries (24) after a median follow-up time of 22 months (0-82 months). These positive results surpass those in the previous follow-up report, where the explanation rate was 1,9% in 1,055 patients (20) observed for a median time of 21 months. In earlier external studies, products available on the market have been shown to be associated with an infection complication rate of over 10% with a high rate of subsequent explanations. Furthermore, histological studies of explanted implants showed clear evidence of integration between the patient's own bone tissue in the skull and the implant already after 9 months. The analysis results are a testament to the regenerative capability of Cranial PSI and a confirmation of OssDsign's ability to develop innovative bone replacement products. The data were collected as part of post-market surveillance in Europe, the U.S., and additional regulatory markets, in accordance with MEDDEV 2.7/1 rev. 4 and MDR 2017/745. Reported Earnings • Nov 18
Third quarter 2021 earnings released: kr0.30 loss per share (vs kr1.10 loss in 3Q 2020) Third quarter 2021 results: Net loss: kr16.5m (loss narrowed 12% from 3Q 2020). Reported Earnings • Aug 21
Second quarter 2021 earnings released: kr0.40 loss per share (vs kr1.30 loss in 2Q 2020) Second quarter 2021 results: Net loss: kr25.3m (loss widened 12% from 2Q 2020). Annuncio • Jun 03
Ossdsign AB (Publ) Announces Innovative Synthetic Bone Graft Outperforms a Comparable Device in Bone Formation Following Spinal Fusion Surgery OssDsign AB (publ) announced that the recently acquired orthobiological product OssDsing Catalyst (previously named Osteo3 ZP Putty) has been evaluated in a preclinical study examining bone formation and function following spinal fusion surgery. The results show that OssDsign Catalyst induced rapid and reliable bone formation and that successful fusion was achieved in 100% of the studied subjects at 26 weeks, compared to 60% in the group where a comparable market-cleared device was used. OssDsign develops patient-specific regenerative implants aimed at restoring cranial bone defects. Following the recent acquisition of Sirakoss Ltd, OssDsign widened its' product portfolio with innovative orthobiologic solutions, including the synthetic bone graft now named OssDsign Catalyst. This innovative product is based on a unique nanocrystalline structure and chemistry, designed to stimulate the formation of healthy bone tissue. Initially, OssDsign Catalyst is being developed for spinal fusion surgeries, a market valued at USD 2.6 billion in 2021. On June 2, 2021, up to 35% of patients treated with spinal fusion do not achieve the desired clinical effect, hence there is a substantial need for new innovative products that can improve healing and bone formation and thereby improve the clinical outcome. In the recently published study, researchers used a validated and widely recognized challenging preclinical fusion model to evaluate OssDsign Catalyst's efficacy in healing bone tissue following spinal fusion surgery. The researchers compared the use of an autograft (the subject's own bone tissue) to the use of OssDsign Catalyst in combination with an autograft, and to a predicate device in combination with an autograft. To evaluate the success rate, measurements and biochemical tissue analyses were conducted at four timepoints, 6, 9, 12 or 26 weeks, following spinal fusion intervention. After 26 weeks, the OssDsign Catalyst group exhibited a 100% success rate in the spinal fusion by all measures, whereas the predicate device group showed 60% success rate. Furthermore, tissue analyses at 26 weeks showed consistent bone formation in the OssDsign Catalyst group, whereas this was not observed in the predicate device group. Annuncio • May 13
OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 240.506091 million. OssDsign AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 240.506091 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 31,033,044
Price\Range: SEK 7.75
Transaction Features: Rights Offering Annuncio • May 05
New Scientific Paper Further Confirms Osteointegration of OssDsign Cranial PSI Implants OssDsign AB announced that independent researchers from Uppsala University Hospital, Sweden, have published a scientific paper in Journal of Neurosurgery describing bone integration in patients implanted with OssDsign Cranial PSI. Samples from four studied patients consistently show vascularized bone, integrating the OssDsign implant with surrounding native bone. This reaffirms the positive findings presented in previously published papers and further strengthens the benefits of OssDsign's custom-made calcium phosphate implants. Patients undergoing cranioplasty - the surgical repair of a bone defect in the skull - often suffer from complications. Reported rates of implant failure ranges from 10% to 30% and the risk of developing surgical site infections is high. Innovative implants, like OssDsign Cranial PSI, can decrease the risk for implant failure by improving osteointegration, thereby reducing the risk of foreign body reaction. The research group at Uppsala University Hospital observed bone and blood vessel formation in the implants in all four studied patients. The integration occurred as effectively in the central parts of the implant as in the bone adjacent parts. In one of the cases the full implant was removed due to a recurrent tumor, but in the three other cases the implants remain in place without signs of implant failure after 33, 36 and 50 months, respectively. The researchers conclude that early and sustained osteointegration of OssDsign implants in cranioplasty occurs and should confer benefits for patients in need of the procedure. Reported Earnings • Apr 21
First quarter 2021 earnings released: kr1.10 loss per share (vs kr1.00 loss in 1Q 2020) The company reported a poor first quarter result with increased losses, weaker revenues and weaker control over costs. First quarter 2021 results: Revenue: kr6.56m (down 23% from 1Q 2020). Net loss: kr23.3m (loss widened 27% from 1Q 2020). Annuncio • Mar 13
Anders Svensson Joins OssDsign AB (Publ) as Chief Financial Officer OssDsign AB (publ) announces that Anders Svensson, the Company's current interim CFO, will take on the role permanently from April 1, 2021. Anders Svensson comes with a strong financial and strategic background and has senior management experience within a number of high growth companies. Prior to joining OssDsign, Anders was CFO for both Bluefish Pharmaceuticals and Aura Light, as well as being the CEO for Aura Light's US business. Anders is Swedish native and holds a Master of Business Administration, Australian Graduate School of Management, University of New South Wales, Sydney, Australia. Is New 90 Day High Low • Feb 18
New 90-day low: €1.35 The company is down 6.0% from its price of €1.43 on 20 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 27% over the same period. Reported Earnings • Feb 12
Full year 2020 earnings released: kr4.40 loss per share (vs kr5.46 loss in FY 2019) The company reported a solid full year result with improved revenues and control over costs, although losses were not reduced. Full year 2020 results: Revenue: kr26.2m (up 46% from FY 2019). Net loss: kr84.6m (flat on FY 2019). Analyst Estimate Surprise Post Earnings • Feb 12
Revenue misses expectations Revenue missed analyst estimates by 7.1%. Over the next year, revenue is forecast to grow 111%, compared to a 14% growth forecast for the Medical Equipment industry in Germany. Annuncio • Jan 21
OssDsign AB (publ) Announces New Clinical Data from 1,055 Cranioplasty Procedures OssDsign AB (publ) announced that updated outcome data on the use of OssDsignCranial PSI in 1,055 cases of cranioplasty and cranial reconstructions have been made public via the company's website. After a median follow-up time of 21 months, rate of infections leading to implant removal was 2.1%, which is consistent with the low levels previously presented. All data were collected as part of post-market surveillance of product performance in Europe, US and selected Asian markets in compliance with MEDDEV 2.7/1 rev.4 and MDR 2017/745. Reconstruction of cranial defects can be a complex surgical procedure associated with an underestimated morbidity. This post-market surveillance report describes the outcome of 1,055 cranioplasties and cranial reconstructions using OssDsign Cranial PSI, a patient-specific implant made from a calcium phosphate material reinforced with 3D-printed titanium. All data were collected as part of post-market surveillance of product performance in Europe, US and selected Asian markets in compliance with MEDDEV 2.7/1 rev.4 and MDR 2017/745. One of the most common causes of explantation of implants are early post-operative infections. In the medical literature, explantation rates due to infection is often seen to reach above 10%. The OssDsign post-market-surveillance data however shows that at a median follow up time of 21 months (range, 0-70 months) only 22 (2.1%) of the implants were explanted due to early postoperative infections. A peer-reviewed clinical study of OssDsign Cranial reported similarly low rates of infections leading to implant removal (1.9%), as has previously reported post-market surveillance data. Is New 90 Day High Low • Dec 05
New 90-day low: €1.36 The company is down 20% from its price of €1.69 on 04 September 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Recent Insider Transactions • Nov 16
Chairman of the Board recently bought €26k worth of stock On the 12th of November, Simon Cartmell bought around 18k shares on-market at roughly €1.49 per share. This was the largest purchase by an insider in the last 3 months. This was Simon's only on-market trade for the last 12 months. Annuncio • Nov 14
Svensson's CFO Claes Lindblad Is Leaving the Company OssDsign AB (publ) announced that CFO Claes Lindblad is leaving the company in order to pursue other opportunities. A leading international recruitment firm has been engaged to lead the search process for a new CFO. Anders Svensson, a highly experienced leader with international experience, will take up the position as interim CFO as of November 16, 2020. Anders Svensson has previous experience from amongst other Aura Light and Bluefish Pharmaceuticals. Reported Earnings • Nov 12
Third quarter 2020 earnings released: kr1.10 loss per share The company reported a solid third quarter result with reduced losses and improved revenues and control over expenses. Third quarter 2020 results: Revenue: kr6.74m (up 39% from 3Q 2019). Net loss: kr18.7m (loss narrowed 4.9% from 3Q 2019). Analyst Estimate Surprise Post Earnings • Nov 12
Revenue misses expectations Revenue missed analyst estimates by 7.4%. Over the next year, revenue is forecast to grow 117%, compared to a 12% growth forecast for the Medical Equipment industry in Germany. Annuncio • Nov 11
OssDsign AB (publ) to Report Fiscal Year 2020 Results on Feb 17, 2021 OssDsign AB (publ) announced that they will report fiscal year 2020 results on Feb 17, 2021 Is New 90 Day High Low • Nov 05
New 90-day low: €1.42 The company is down 6.0% from its price of €1.51 on 07 August 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Aug 19
OssDsign AB (publ) Announces Chief Executive Officer Changes OssDsign AB (publ) announced appointment of Morten Henneveld as Chief Executive Officer upon the retirement of Anders Lundqvist on September 1, 2020.