We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Orthofix (OFIX) Secures FDA 510k Clearance for OsteoCove Graft
Read MoreHide Full Article
Orthofix Medical Inc. (OFIX - Free Report) recently gained FDA 510k clearance for its advanced bioactive synthetic graft, OsteoCove. Following the approval, the company announced the full commercial launch of the same.
The latest development significantly strengthens Orthofix’s biologics portfolio of the Global Spine segment and builds on its mission to deliver best-in-class products to every major bone-grafting category.
More on OsteoCove
The company recognizes OsteoCove as a prime example of leveraging its strengths in product development in combination with its vertically integrated manufacturing expertise. Available in both a putty and strip configuration, OsteoCove was carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range of spine and orthopedic procedural applications.
Image Source: Zacks Investment Research
The product is made of biphasic ceramic granules comprised of β-tricalcium phosphate and hydroxyapatite combined with type-I bovine collagen. OsteoCove features a specialized granule surface topography designed to elicit a bone-forming response, as demonstrated by its ability to grow bones in a challenging muscle pouch model. This specialized surface chemistry and microporosity are shown to promote superior bone formation compared to other commercially available advanced synthetic grafts.
News in Detail
Orthofix’s spokesperson said that they have used the same disciplined R&D approach in creating the OsteoCove graft, which they have historically taken with respect to the internally processed demineralized bone matrix solutions. The company continues to deliver on its commitment to provide surgeons with a comprehensive offering of biologic solutions to meet their patients’ needs.
OsteoCove’s introduction is expected to generate strong growth in the large synthetic bone graft market segment, which challenges the performance expectations of typical synthetic bone graft substitutes.
Industry Prospects
Per a research report, the global bone graft and substitute market was valued at $2.80 billion in 2022 and is expected to witness a CAGR of 6.3% by 2030.
Other Highlights Within the Global Spine Segment
In August 2023, OFIX announced the full commercial launch and successful completion of the first cases in the United States with the 7D FLASH Navigation System Percutaneous Module 2.0. The launch expands the clinical functionality and utility of the 7D FLASH Navigation System by providing surgeons with a fully integrated procedural solution for Minimally Invasive Surgery, including implant planning and an expanded offering of navigated tools.
In June 2023, Orthofix made the full commercial availability of the WaveForm A interbody for Anterior Lumbar Interbody Fusion procedures. The system integrates the most advanced technologies into the company’s surgical sets, minimizing the need for multiple instrument sets during the procedure.
Price Performance
Over the past year, Orthofix shares have decreased 18.3% compared with the industry’s decline of 1.9%.
Zacks Rank and Key Picks
Orthofix currently carries a Zacks Rank #3 (Hold).
Cardinal Health stock has risen 31.1% in the past year. Earnings estimates for the company have increased from $6.65 to $6.66 in 2023 in the past 30 days and from $7.56 to $7.57 for 2024 in the past seven days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.03%. In the last reported quarter, it posted an earnings surprise of 4.73%.
Estimates for Haemonetics’ 2023 earnings per share have remained constant at $3.82 in the past 30 days. Shares of the company have increased 13.1% in the past year against the industry’s decline of 10.3%.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 29.7% in the past year compared with the industry’s growth of 19.1%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Orthofix (OFIX) Secures FDA 510k Clearance for OsteoCove Graft
Orthofix Medical Inc. (OFIX - Free Report) recently gained FDA 510k clearance for its advanced bioactive synthetic graft, OsteoCove. Following the approval, the company announced the full commercial launch of the same.
The latest development significantly strengthens Orthofix’s biologics portfolio of the Global Spine segment and builds on its mission to deliver best-in-class products to every major bone-grafting category.
More on OsteoCove
The company recognizes OsteoCove as a prime example of leveraging its strengths in product development in combination with its vertically integrated manufacturing expertise. Available in both a putty and strip configuration, OsteoCove was carefully formulated to provide superior bone-forming capabilities with best-in-class handling characteristics for a wide range of spine and orthopedic procedural applications.
Image Source: Zacks Investment Research
The product is made of biphasic ceramic granules comprised of β-tricalcium phosphate and hydroxyapatite combined with type-I bovine collagen. OsteoCove features a specialized granule surface topography designed to elicit a bone-forming response, as demonstrated by its ability to grow bones in a challenging muscle pouch model. This specialized surface chemistry and microporosity are shown to promote superior bone formation compared to other commercially available advanced synthetic grafts.
News in Detail
Orthofix’s spokesperson said that they have used the same disciplined R&D approach in creating the OsteoCove graft, which they have historically taken with respect to the internally processed demineralized bone matrix solutions. The company continues to deliver on its commitment to provide surgeons with a comprehensive offering of biologic solutions to meet their patients’ needs.
OsteoCove’s introduction is expected to generate strong growth in the large synthetic bone graft market segment, which challenges the performance expectations of typical synthetic bone graft substitutes.
Industry Prospects
Per a research report, the global bone graft and substitute market was valued at $2.80 billion in 2022 and is expected to witness a CAGR of 6.3% by 2030.
Other Highlights Within the Global Spine Segment
In August 2023, OFIX announced the full commercial launch and successful completion of the first cases in the United States with the 7D FLASH Navigation System Percutaneous Module 2.0. The launch expands the clinical functionality and utility of the 7D FLASH Navigation System by providing surgeons with a fully integrated procedural solution for Minimally Invasive Surgery, including implant planning and an expanded offering of navigated tools.
In June 2023, Orthofix made the full commercial availability of the WaveForm A interbody for Anterior Lumbar Interbody Fusion procedures. The system integrates the most advanced technologies into the company’s surgical sets, minimizing the need for multiple instrument sets during the procedure.
Price Performance
Over the past year, Orthofix shares have decreased 18.3% compared with the industry’s decline of 1.9%.
Zacks Rank and Key Picks
Orthofix currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Cardinal Health (CAH - Free Report) , Haemonetics (HAE - Free Report) and Align Technology (ALGN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardinal Health stock has risen 31.1% in the past year. Earnings estimates for the company have increased from $6.65 to $6.66 in 2023 in the past 30 days and from $7.56 to $7.57 for 2024 in the past seven days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.03%. In the last reported quarter, it posted an earnings surprise of 4.73%.
Estimates for Haemonetics’ 2023 earnings per share have remained constant at $3.82 in the past 30 days. Shares of the company have increased 13.1% in the past year against the industry’s decline of 10.3%.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 29.7% in the past year compared with the industry’s growth of 19.1%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.