Spondylolysis

BURLINGTON, Mass.--( BUSINESS WIRE )-- Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, reports progress with advancing its product candidate NB1 into human clinical testing for spinal fusion. Following Human Research Ethics Committee (HREC) approval last year in Australia for the multicenter, prospective, randomized pilot clinical trial, the Company reports that three hospital sites have been engaged to participate in the pilot clinical trial. This pilot clinical trial will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD). Inclusion criteria include patients with DDD at one level from L2-S1 who may also have up to Grade 1 spondylolisthesis or Grade 1 retrolisthesis at the involved level. The study design was previously reviewed and agreed upon by the Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States. About NB1 rhNELL-1 is a recombinant human protein that is combined with demineralized bone matrix to form the Company’s product candidate NB1. NELL-1 has unique properties that suggest it will be ideal in treating spinal fusion, trauma, osteoporosis and other bone-related indications, and may be especially useful among so-called “hard healers.” This potential lies in its ability to provide rapid, specific and guided control over bone regeneration. For the NB1 bone graft device, the inclusion of rhNELL-1 provides an ancillary osteopromotive effect that is expected to increase the incidence. The proposed mechanism of action for rhNELL-1 to improve bone formation is based on published research and involves classic receptor binding and intracellular signaling transduction to the nucleus to promote osteogenic gene expression and bone formation. There is a large and established opportunity for NB1 with an estimated global market of $3 billion annually for bone graft substitutes in spine fusion for products such as growth factors, DBM, synthetic materials, stem cells and allografts. Additional longer-term market opportunities include the $11 billion annual market for treating osteoporosis and the $8 billion annual market for treating trauma. About Bone Biologics Bone Biologics was founded to pursue regenerative medicine for bone. The Company is working with select strategic partners to build on the foundation of preclinical research on rhNELL-1. Bone Biologics is focusing development efforts for its NB1 bone graft device in spinal fusion procedures, while additionally having rights to trauma and osteoporosis applications. For more information, please visit www.bonebiologics.com . Forward-Looking Statements Certain statements contained in this press release, including, without limitation, statements regarding the timing, implementation, and success of our pilot clinical trial of NB1 in human subjects with DDD, as well as statements containing the words “plan,” “will,” “expected” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including, but not limited to, market and other conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Global study will assess the safety and efficacy of the company's lead spinal fusion product, OsteoAdapt SP FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion. With an aging population, more people will suffer from debilitating spinal conditions. Around 40% of adults over the age of 40 and 80% of adults over the age of 80 have at least one degenerated vertebral disc. Currently, more than 1 in 6 Americans are over the age of 65 and this proportion is increasing. However, current spinal fusion treatments can leave patients with sub-optimal outcomes, and often suffering from excruciating pain. Theradaptive's spinal fusion product, OsteoAdapt SP, aims to provide safer and more effective treatments for transforaminal lumbar interbody fusion (TLIF) procedures, whereby vertebrae in the lower back are fused in a minimally invasive posterior procedure. It is used for a range of conditions including degenerative disc disease, lumbar spondylolisthesis, and spinal stenosis. Theradaptive's therapeutic platform aims to improve efficacy and safety by creating material-binding variants of recombinant proteins that bind to medical devices, implants and injectable carriers to achieve anatomically-precise and locally-sustained therapeutic delivery. IDE approval from the FDA serves as a key milestone for this platform and will generate its first human clinical data, thus opening a new chapter in Theradaptive's growth into a clinical-stage company. Starting in April, this study of 80 patients will assess the safety and efficacy of OsteoAdapt SP. The feasibility study will also identify the required OsteoAdapt SP dose that will be investigated in a future pivotal study. The study will produce early interim data to permit interim assessments of safety and efficacy. More details can be found at ClinicalTrials.gov identifier NCT06154005. Theradaptive's path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols. John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: "The FDA created Breakthrough Device Designations to accelerate the clinical trials and approval processes for devices that promise to improve on current treatments for life-threatening and debilitating conditions. The fact that OsteoAdapt has been awarded three Breakthrough Device Designations is an indicator of the ground-breaking nature of the technology. The FDA has extensive experience with rh-BMP2, which was used to design the AMP2 biologic within OsteoAdapt. Based on the safety profile of OsteoAdapt, we will be allowed to combine Phase I and II trials. We can now apply these insights to our other programs in dental, orthopedics, and sports medicine." Dr. Brett Freedman, Chair, Spine Surgery Division, Mayo Clinic said: "The FDA's approval to combine Phase I and II into one feasibility trial, along with three Breakthrough Designations is a strong signal that OsteoAdapt SP shows promise to significantly improve our current therapeutic offerings in the area of bone graft, and more importantly that OsteoAdapt SP represents a valid solution to long unmet needs in spinal fusion. OsteoAdapt has beaten the standard of care in every preclinical study to date and we're excited by the prospect of proving the same in humans and overcoming limitations with the current standard of care". Theradaptive's clinical work is supported in part by a Department of Defense Clinical Trial Award under the Peer Reviewed Medical Research Program and the Maryland Stem Cell Research Fund. In addition to spine, Theradaptive has active development programs in trauma, orthopedic, dental, craniomaxillofacial repair, and bone-tendon and bone-ligament repair for sports medicine indications, all based on the OsteoAdapt product. The company is actively collaborating with physicians to advance each of those indications into the clinic on the back of its IDE approval in spine. Theradaptive CEO and founder Luis Alvarez, PhD, commented on synergies with these other programs: "Advancing OsteoAdapt into the clinic under this IDE will also enable acceleration of partnered programs that use OsteoAdapt as a component. One key example is our partnership with 3D Systems where we are developing products that incorporate OsteoAdapt in 3D printed implants using our OrthoTex 3D printable graft containment system. This accelerates the development of truly regenerative 3D printed implants for applications in cranial repair and sports medicine." About Theradaptive Founded in 2016 and headquartered in Maryland, U.S., Theradaptive is a venture-backed biopharmaceutical and medical device company with the goal of leveraging its therapeutic delivery platform to deliver biologics where they are needed in the body with high local precision and high persistence to address unmet medical needs. Theradaptive's innovative platform is enabling the development of new therapeutics in spine, orthopedics, and soft tissue repair as well as targeted immuno-oncology. The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $7,408,939, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Contact: Marcus McCabe [email protected] SOURCE Theradaptive

NEW YORK, Sept. 11, 2023 /PRNewswire/ -- Prominently featured in The Inner Circle, Andrew Jonathan Cordiale, DO, MS, is acknowledged as a Top Pinnacle Professional in the field of Orthopedic Spinal Surgeon. Dr. Cordiale launched his pursuit of higher education at the New York Institute of Technology College of Osteopathic Medicine where he graduated in the top 10% of his class and ranked in the 99th percentile on his medical licensing exam. He earned two Master's degrees: a Master of Science degree in Neuromuscular-skeletal Science; and a Master of Science degree in Clinical Nutrition, while studying for his medical degree and graduated with distinction. Recognized as an exceptional student, Dr. Cordiale was also 1 of 2 medical students in his class awarded a scholarship as a Pre-Doctoral Fellow in Anatomical Science. A testament to his professionalism and leadership abilities, the doctor was elected to serve as a chief of his intern class and continued orthopedic training at North Shore / Long Island Jewish Healthcare Systems (Plainview Hospital). He also served as a chief resident and scored within the top 94th percentile on his orthopedic in-service training exams (OITE). Dr. Cordiale completed his formal education with a fellowship in complex spine surgery at the world-renowned Norton Leatherman Spine Center in Louisville, Kentucky. Board-certified as an orthopedic spinal surgeon, Dr. Cordial asserts that he deeply cares about his patients and his community. "My goal is to improve my patient's quality of life. Even as a surgeon, I firmly believe the first step is to utilize no operative treatments to the fullest extent possible. Although surgery is a powerful and excellent treatment modality, in many cases surgery should be the last option," the doctor explained. Ranked the 11th highest in the country on the written orthopedic board exam, Dr. Cordiale is a Diplomate of the American Osteopathic Board of Orthopedic Surgery (AOBOS). He notes the AOBOS is an organization that provides board certification to qualified Doctors of Osteopathic Medicine who specialize in the medical and surgical treatment of disorders of the musculoskeletal system. Dr. Cordiale explained that he is an expert in spondylolisthesis, a form of spinal instability, and that his research on this topic has been presented at international spinal surgery conferences in Europe (IMAST); North America (NASS); and the United States (AAOS). The doctor has also co-authored a book chapter on this condition. Orthopedic surgery, according to Dr. Cordiale, is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopedic surgeons, such as the doctor, use both surgical and non-surgical means to treat musculoskeletal trauma; spine diseases; sports injuries; degenerative diseases; infections; tumors; and congenital disorders. His illustrious career and prestigious education has propelled Dr. Cordiale to the top of his field and he has been recognized with a multitude of honors, including the Patients Choice Award (2020); On-Time Doctor Award (2020); and Compassionate Doctor Recognition (2020). Aside from his professional pursuits, Dr. Cordiale volunteers on a local level at Brookhaven National Laboratory on cancer research and the State University of New York at Stony Brook University Medical Center. He has also served as an Emergency Medical Technician on Long Island and served in an international capacity as a volunteer at the Guatemalan Healing Hand Foundation. Contact: Katherine Green 516-825-5634 [email protected] SOURCE The Inner Circle