16 Jul Bioventus Launches OSTEOAMP® SELECT Flowable Nationwide
DURHAM, N.C., July 13, 2021 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, is launching OSTEOAMP SELECT Flowable, a flowable allograft bone graft substitute solution developed for a variety of patient procedures including lumbar spine fusion, cervical spine fusion and foot & ankle fusion.
Introduced in a limited release in select US markets beginning in March 2021, OSTEOAMP SELECT Flowable is 100 percent allograft with no synthetic carrier added, yet still based on the unique OSTEOAMP process designed to retain a wide array of essential growth factors.1* Its versatile handling is designed to satisfy the need for a flowable allograft product with cohesive properties, making it an attractive option for minimally invasive surgery (MIS), expandable cages and 3D-printed cages.
“Spine, trauma and foot & ankle surgeons are looking for allograft options that handle well for a variety of procedures,” said Dr. Larry Boyd, Vice President, Product Development, Bioventus. “Developed by our team in collaboration with our tissue bank partner, OSTEOAMP SELECT Flowable comes ready-to-use, and is designed to be delivered in a range of methods, and to provide excellent retention characteristics at the grafting site. It is terminally sterilized and processed using advanced procedures designed to comply with the highest standards for tissue banking, including comprehensive donor screening and extensive microbiological testing.”
“OSTEOAMP SELECT Flowable has been an ideal product for a variety of my minimally invasive interbody fusions, particularly with expandable cage technology, where I need a graft that handles efficiently to navigate tight spaces,” said Dr. Paul Kim, Carolina Neurosurgery & Spine Associates. “I have used various formats of OSTEOAMP for years and have seen firsthand the successful patient outcomes it can help provide.”
“A differentiated allograft product with the handling characteristics like OSTEOAMP SELECT Flowable is an asset for a spine surgeon who uses 3D printed cages where grafting can be challenging,” said Dr. Safdar Khan, Ohio State University. “I was impressed to see how the flowable product filled a cage with a tight, porous structure so well and stayed in place during implantation.”
OSTEOAMP SELECT Flowable comes in three sizes from 2.5 to 10 cc and is available nationwide. To learn more, visit www.bioventussurgical.com
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter.
OSTEOAMP, Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
- Tidwell JL., Seaman SA, Vanderploeg EJ, Tom S. In vitro and in vivo characterization of OSTEOAMP allogenic morphogentic proteins. Data on file. Bioventus white paper, 2017.
Summary of Indications for Use
OSTEOAMP may be used in situations where an autograft is appropriate. It should be restricted to homologous use for the repair, replacement, or reconstruction of musculoskeletal defects. Please see instructions for use for a complete list of indications, contraindications, warnings, and precautions on the product label, at www.bioventussurgical.com or by calling 1-800-637-4391.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements concerning the expected benefits, clinical development and market opportunities of OSTEOAMP SELECT Flowable. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release include, but are not limited to, statements about the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to differentiate the hyaluronic acid (“HA”) viscosupplementation therapies we own or distribute from alternative therapies for the treatment of osteoarthritic; the proposed down-classification of non-invasive bone growth stimulators, including our Exogen system, by the U.S. Food and Drug Administration (“FDA”); our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner; competition against other companies; the negative impact on our ability to market our HA products due to the reclassification of HA products from medical devices to drugs in the United States by the FDA; our ability to attract, retain and motivate our senior management and qualified personnel; our ability to continue to research, develop and manufacture our products if our facilities are damaged or become inoperable; failure to comply with the extensive government regulations related to our products and operations; enforcement actions if we engage in improper claims submission practices or in improper marketing or promotion of our products; the FDA regulatory process and our ability to obtain and maintain required regulatory clearances and approvals; failure to comply with the government regulations that apply to our human cells, tissues and cellular or tissue-based products; the clinical studies of any of our future products that do not product results necessary to support regulatory clearance or approval in the United States or elsewhere; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including Bioventus’ Annual Report on Form 10-K for the period ended December 31, 2020, as such factors may be updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.
Mike Piccinino, CFA, IRC
SOURCE: Globe Newswire, 13th July 2021