MADISON HEIGHTS, MICHIGAN (PRWEB) FEBRUARY 22, 2017 Becker’s Spine Review, the leading publication featuring news and analysis of issues related to spine practices, is featuring Michigan neurosurgeon Jay Jagannathan, M.D., as a “Spine Surgeon to Know.” Dr. Jagannathan is known as one of a small number of neurosurgeons in Michigan performing minimally invasive back surgery that often results in less post-operative discomfort and a quicker recovery for patients. Dr. Jagannathan founded and heads the Jagannathan Neurosurgical Institute – with clinical-office locations in the Detroit area (Madison Heights, Garden City, Dearborn and soon in Troy), central Michigan (West Branch) and far-northern Michigan (Sault Sainte Marie). The practice has specialists in neurosurgery, neurology and pain management and provides interdisciplinary treatment for patients with spine and other neurological disorders throughout the state of Michigan. “It is a great honor to be featured by Becker’s Spine Review,” said Dr. Jagannathan of the Jagannathan Neurosurgical Institute. “We are recognized for the specialty expertise in minimally invasive spine surgery, which our patients really appreciate, and also our unusual reach in the state of Michigan – with office locations and my ability and willingness to travel to be nearby just about anyone in Michigan, regardless of where they live in the state.” Dr. Jagannathan is a Diplomate of the American Board of Neurological Surgery, the American Academy of Neurological and Orthopedic Surgery and the American Board of Spinal Surgery. He has been a “Featured Neurosurgeon” in Hour Detroit magazine’s ‘Top Docs’ issue in 2014, 2015 and 2016. He received the Patients’ Choice Award and Compassionate Doctor Recognition from Vitals.com in 2014, 2015 and 2016. In 2016 he was rated the Top Neurosurgeon in Metro Detroit by RateMDs.com. Dr. Jagannathan received his M.D. degree from the University of Maryland School of Medicine. His neurosurgery residency was at the University of Virginia Health Sciences Center and the Wayne State University School of Medicine where he was Chief Resident. He is a Fellow of the American Association of Neurological Surgeons. Dr. Jagannathan has published numerous papers and book chapters in the areas of spine surgery, radiosurgery and neuro-oncology and has been the recipient of numerous awards including the Synthes Award for craniofacial research as well as the Cone Pevehouse Award for socioeconomic research, both from the American Association of Neurological Surgeons. He was named a ‘rising star’ in spine surgery by In-Spine magazine. He is actively involved in organized neurosurgery and served as a member of the American Association of Neurological Surgeons (AANS) Young Neurosurgeons Committee and on the Executive Committee of the Section on Tumors. He also represented Michigan on the Council of State Neurosurgical Societies. Dr. Jagannathan is a resident of Birmingham, Mich.Read More
WALTHAM, Mass., July 31, 2018 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, today announced the appointment of E. Lynne Kelley, M.D., FACS as its Chief Medical Officer. Dr. Kelley brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Dr. Kelley will join Histogenics’ executive team and assume responsibility for leading medical affairs strategy and building out the department in anticipation of NeoCart’s potential commercial launch. Dr. Kelley will also work with the team on preparing the anticipated Biologics License Application (BLA) for NeoCart and spearheading related discussions with the United States Food and Drug Administration (FDA).
“Lynne’s experience as a surgeon, medical affairs executive and educator across a wide variety of therapeutic areas and indications will be critical for Histogenics as we prepare for our top-line data, potential BLA submission and FDA review of NeoCart,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We are pleased to have Lynne join us at this exciting time to educate our customers and patients about the benefits of our novel restorative cell therapy platform through training, medical education and collaboration with our future commercial team. In addition, she will be working closely with our team to help drive additional product development initiatives, such as future trials in the U.S. and internationally.”
Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in Biology from Boston University. Prior to Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Corporation’s (Boston Scientific) Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University.
“I am thrilled to join the talented, cutting edge team at Histogenics. The potential of NeoCart in restoring function and thus improving the lives of patients with debilitating joint pain is extraordinary,” shared Dr. Kelley. “I look forward to collaborating with the physician community globally to bring this exciting therapy to our patients.”
In connection with the hiring of Dr. Kelley, the Compensation Committee of Histogenics’ Board of Directors approved a grant to Dr. Kelley of a stock option to purchase 200,000 shares of Histogenics’ common stock. The option was granted pursuant to the Nasdaq inducement grant exception as a component of Dr. Kelley’s employment compensation, and was granted as an inducement material to her acceptance of employment with Histogenics in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Histogenics’ common stock on July 31, 2018. The option has a ten year term and vests with respect to 25% of the shares of common stock underlying the option on the one year anniversary of Dr. Kelley’s first day of employment with Histogenics and with respect to the remaining shares in equal monthly installments over the following 36 months, subject to Dr. Kelley’s continued service with Histogenics through the applicable vesting dates.
About Histogenics Corporation
Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in the second quarter of 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial , including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018. In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.
There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.Read More
WARSAW, Ind., July 31, 2018 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that FIREFLY® Pedicle Screw Navigation Guides (“FIREFLY”) received additional FDA 510(k) clearance for an expanded indication to include S2AI [screw] trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries, including scoliosis. When applied to the challenging S2AI trajectory, the precise and personalized mechanical guidance enabled by FIREFLY minimizes complexities associated with crossing the sacral-iliac joint while eliminating the need for excessive radiation/fluoroscopy.
OrthoPediatrics is the exclusive distributor of FIREFLY technology in children’s hospitals in the US. FIREFLY is FDA-cleared for use in adult and pediatric populations and is manufactured by Mighty Oak Medical.
The patient-specific, 3D printed FIREFLY Pedicle Screw Navigation Guides are a novel solution to complex and costly navigation systems. This patented navigation technology is designed to increase OR efficiency and eliminate the need for intraoperative radiation, making it the optimal choice in more complicated spinal construct cases, such as those involving the S2AI trajectory.
David Bailey, Executive Vice President of OrthoPediatrics, commented, “We are pleased our partners at Mighty Oak Medical have received additional FDA clearance for this enhancement of the FIREFLY technology. This signifies another pediatric patient segment that surgeons now can treat efficiently and effectively. Ensuring our customers and their patients have access to this novel technology is one more way we continue leading innovation in pediatric orthopedics.”About Mighty Oak Medical Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to email@example.com.
About OrthoPediatrics Corp. Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.Investor Contacts The Ruth Group Tram Bui / Emma Poalillo (646) 536-7035 / 7024 firstname.lastname@example.org / email@example.com Read More
CARLSBAD, Calif., July 30, 2018 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the quarter ended June 30, 2018 and updated its financial outlook for 2018.Summary Second Quarter 2018 Financial Results and Recent Accomplishments
- Revenue of $36.4 million, an increase of 6.5% year-over-year
- U.S. revenue of $32.6 million, an increase of 7.5% year-over-year
- U.S. Spinal Implants revenue of $16.0 million, an 11.5% increase year-over-year
- U.S. Orthobiologics revenue of $16.6 million, a 4.0% increase year-over-year
- Renewed credit facility with Wells Fargo Bank to extend three years through July 2021, with an option to increase the limit by $10 million to $40 million
- Transitioned OsteoStrand™ Demineralized Bone Fibers to full commercial launch
- Received 510(k) clearance and launched instrumentation designed for use with frequently used third-party surgical navigation system
- Launched comprehensive posterior decompression and disc preparation instrument system
|SEASPINE HOLDINGS CORPORATION UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Total revenue, net||$||36,409||$||34,196||$||69,584||$||66,090|
|Cost of goods sold||14,560||13,994||26,739||27,166|
|Selling, general and administrative||25,432||24,249||49,899||48,219|
|Research and development||2,791||3,344||5,580||6,394|
|Total operating expenses||29,015||28,385||57,063||56,197|
|Other (expense) income, net||(157||)||185||(137||)||172|
|Loss before income taxes||(7,323||)||(7,998||)||(14,355||)||(17,101||)|
|Provision for income taxes||38||45||111||45|
|Net loss per share, basic and diluted||$||(0.50||)||$||(0.68||)||$||(1.01||)||$||(1.46||)|
|Weighted average shares used to compute basic and diluted net loss per share||14,590||11,888||14,339||11,705|
|SEASPINE HOLDINGS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEET DATA (In thousands)|
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||13,263||$||10,788|
|Trade accounts receivable, net of allowances of $474 and $466||20,894||21,872|
|Total current liabilities||24,719||23,157|
|Long-term borrowings under credit facility||4,000||—|
|Total stockholders' equity||101,562||105,653|
LONDON, July 31, 2018 /PRNewswire/ -- Bone Grafts and Substitutes Market Size, Share & Trends Analysis Report By Material Type (Natural, Synthetic), By Application Type (Spinal Fusion, Craniomaxillofacial, Long Bone), By Region, And Segment Forecasts, 2018 - 2025.
Download the full report: https://www.reportbuyer.com/product/5479697
The global bone grafts and substitutes market size is expected to reach USD 3.9 billion by 2025, according to a new report by Grand View Research, Inc. The market is expected to register a healthy CAGR of 5.5% during the forecast period. Demand for bone grafts and substitutes is increasing due to adoption of newer technologies and increasing demand for minimally invasive procedures.
Availability of advanced products in varied shapes and sizes providing high osteoconductive and osteoinductive properties is supporting market growth.Moreover, growing adoption of minimally invasive procedures is spurring demand for bone grafts and substitutes.
In minimally invasive procedures, large incisions and damage to muscles surrounding repair area can be significantly avoided.These techniques also reduce the duration of hospital stay and support rapid wound healing with lesser pain and surgical wounds.
Minimally invasive total joint replacement and spine surgeries are some of the newly adopted procedures. Some of the companies in the bone grafts and substitutes market are DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.
Further key findings from the study suggest:
• Increasing number of orthopedic surgeries and rising demand for minimally invasive surgeries are primary factors driving market growth
• By material type, allografts accounted for the largest market share within the natural segment in 2016, mainly due to properties such as immediate structural support and osteoconductivity. Moreover, allografts do not require another surgery to harvest the bone, which results in reduced surgery time and wound healing, thus, attributing toward segment growth
• North America is the leading regional market, followed by Europe. Rising awareness regarding commercially available products, higher healthcare expenditure, and availability of advanced healthcare infrastructure are prime factors responsible for the region's expansion
• Key players in the market include DePuy Synthes; Medtronic PLC; Nuvasive, Inc.; Orthofix Holdings, Inc.; Wright Medical Group N.V.; AlloSource, Inc.; and Stryker Corp.
Download the full report: https://www.reportbuyer.com/product/5479697
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Episurf Medical has received initial feedback from the US FDA on the IDE application for the Episealer® knee implant
Episurf Medical (NASDAQ: EPIS B) today announces that the company has received initial feedback from the US Food and Drug Administration (FDA) on the Investigational Device Exemption (IDE) application for the Episealer® knee implant that was submitted in June. The company filed the IDE application to get approval to initiate a clinical study in the US. Episurf Medical has now received communication on the IDE application within 30 days according to FDA’s communicated timetable and now has some details to address prior to a finalised IDE study design will be set. “We are now entering into the next phase for the IDE application. Episurf considers the FDA feedback as manageable and we are looking forward to continued work with our advisors to get the IDE study up and running according to our initial schedule” comments Pål Ryfors, CEO, Episurf Medical. For more information, please contact: Pål Ryfors, CEO, Episurf Medical Tel:+46 (0) 709 62 36 69 Email: firstname.lastname@example.org About Episurf Medical Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com. This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 30 July 2018. Tags:Read More
CloudMedx Working With UCSF to Create AI Models for Improving Patient Outcomes After Joint Replacement Surgery
PALO ALTO, Calif., July 30, 2018 (GLOBE NEWSWIRE) -- CloudMedx, a healthcare artificial intelligence (AI) company based in Palo Alto, Calif., announced today a research collaboration with the UCSF Department of Orthopaedic Surgery to study how patient-generated health care data collected from consumer-grade wearable sensors may predict clinical outcomes following hip and knee replacement surgery.
By looking at structured and unstructured data from patient medical records, as well as from wearable devices, the UCSF research team, advised by the National Science Foundation’s Center for Disruptive Musculoskeletal Innovations, aims to create a new class of algorithms that can predict a patient’s individual outcome and recovery following surgery.
“We want to combine patient-reported outcomes, data from electronic medical records and sensor data to predict how patients will recover following joint replacement surgery,” said project leader Stefano Bini, MD, UCSF Health orthopedic surgeon and professor of orthopedic surgery at UCSF. “To give us a perspective on how patients are doing with predictive analytics, we partnered with CloudMedx to handle the large data sets that will be needed.”
According to Dr Bini, the current gold standard for patient evaluations are validated patient reported outcome surveys, which are obtained prior to surgery and at one year following surgery, when the maximum improvement is deemed to have been reached. However, data points gathered in the interim have not been validated and are generally discouraged.
“The hope is that we can overcome these shortcomings by gathering data from sensors that can objectively measure in real time steps, cadence, heart rate and other variables with a patient’s clinical record to accurately predict their outcomes,” Dr. Bini said. “There currently is a huge cache of unstructured information in the medical records in the form of physician notes, nurse progress notes, discharge summaries, radiology notes and patient-reported outcomes that is being overlooked due to lack of resources. By using CloudMedx’s robust AI to read clinical notes using machine-assisted natural language processing, we aim to surface insights in real time to improve patient outcomes.”
According to Dr Bini, “Engaging Cloudmedx as our analytics platform allowed us to derive relationships and incredible insights using state of the art ML algorithms. Rather than the standard and rather useless calculation of relative Hazard and Risk Ratios of one outcome versus another when looking at one variable and adjusting for all others (“useless” because the resulting data is incredibly hard to apply in clinical practice where patients present with multiple variables many of which like gender and age are not at all variable), the algorithm was able to clearly identify cohorts (clusters) of people whose variables (features) were more likely to be associated with a given outcome (PRO) and take any specific candidate and place them in a risk cluster. This is phenomenal and way more practical.”
Very preliminary data was presented this spring at the Orthopedic Research Society. Early signals have demonstrated what kind of data is predictive of what kind of outcome and that it may predict 6-week PROs with a high degree of accuracy in a given individual as early as 2 weeks following surgery.
About CloudMedx CloudMedx is a clinical artificial intelligence platform that provides real time clinical insights to the healthcare industry with the goal of improving clinical and operational outcomes. The company uses evidence-based algorithms, machine learning and natural language to sift through both unstructured data as well as structured data to help providers and health systems improve care delivery, reduce costs, and optimize their workflows. For more information, visit www.cloudmedxhealth.com.
UC Disclaimer The information stated above was prepared by CloudMedx to report on research conducted on its product and reflects solely the opinion of CloudMedx. Nothing in this statement shall be construed to imply any support or endorsement of CloudMedx, or any of its products, by The Regents of the University of California, its officers, agents and employees.Sahar Arshad CloudMedx Inc 650.769.4199 Read More
Kevin Krause, Federal Courts Reporter / Photo: (Jae S. Lee/Staff Photographer) While federal prosecutors in Dallas prepare for upcoming health care fraud trials, the FBI and other investigators are continuing to raid more medical businesses, looking for evidence of illegal kickbacks. Last week, the FBI searched the Dallas offices of Next Health, which owned a network of testing labs and pharmacies. Next Health is already facing fraud allegations from insurance giant United Healthcare, which claims the company gave people gift cards to urinate in cups in Whataburger bathrooms. The FBI also searched the offices of Critical Health Care Management, which agents say took over Next Health’s operations. Andrew Hillman and Semyon Narosov, who allegedly control both businesses, are charged with health care fraud in an unrelated federal case in Dallas involving the defunct Forest Park Medical Center. Next Health is one of several Dallas-area health care businesses that are currently the subject of federal indictments and investigations. The recent raids indicate the government is not done cracking down on testing labs and compounding pharmacies, which have been a focus of kickback investigations nationwide for the past few years. Michael McCaslin, a Dallas FBI agent, said during a July 24 court hearing that the bureau is looking at whether Next Health paid kickbacks to doctors for referring patients to the company’s pharmacies. The agent also said Next Health is suspected of using animal drugs in its pharmacies and manipulating ingredients to overcharge insurance companies. McCaslin said doctors invested in Next Health’s pharmacies and were paid kickbacks in the form of dividends that in some cases were tied to the volume of their referrals. “You had to be prescribing or else you’d be asked to leave,” the agent said. McCaslin’s testimony was given during a detention hearing for Hillman and Narosov, who were recently arrested on drug distribution charges related to a marijuana dispensary they allegedly owned in Los Angeles. An attorney for Next Health did not respond to requests for comment about the raids and FBI investigation. READ THE REST HERERead More
By Christina Jewett / July 30, 2018 Medicare is reviewing whether seniors should undergo spine surgeries at same-day surgery centers, the government-run health program announced Wednesday, five months after a USA Today Network-Kaiser Health News investigation revealed a spate of patient deaths following the procedures. The proposal states that Medicare officials will examine whether these procedures “pose a significant safety risk” to patients and continue to “meet the criteria” for Medicare payment. The news investigation found that in 2015 and in 2017 Medicare approved same-day spine operations for seniors even though at least 14 patients had died since 2008 after such procedures. Some suffocated from a well-known complication of upper-spine surgery that can generally be reversed if caught immediately and treated properly. The investigation also found that some medical professionals urging Medicare to pay surgery centers to operate on seniors’ spines failed to mention recent incidents of death at their own or an affiliated facility. Dr. Nancy Epstein, a chief of neurosurgical and spine education at New York University Winthrop Hospital, lauded the proposal, saying patients face extensive risks after spine surgery. “It’s about time,” Epstein said of the review proposal, which she expects to rankle some doctors who have a financial stake in a spine surgery center. Bill Prentice, executive director of the Ambulatory Surgery Center Association, which represents the centers in policymaking discussions, said he supports Medicare stepping up its efforts to perform an internal and external review of the procedures it pays for at surgery centers. “The more resources they use, the better,” Prentice said. “I think that the more data points they have, the more likely they are to make the right decision. … We believe these procedures can be performed very safely in the ambulatory surgery center space.” Medicare announced the plan to re-evaluate its decision to pay for seniors’ spine procedures in an annual rule-making document released Wednesday. The agency is accepting comments on the proposed changes through Sept. 24 and is expected to release a final decision late in the year. READ THE REST HERERead More
Cerapedics Announces First Patients Enrolled in IDE Clinical Trial of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery
WESTMINSTER, Colo., July 30, 2018 /PRNewswire/ -- Cerapedics, a privately-held orthobiologics company, today announced that the first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgery.
The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include a total of 364 patients with degenerative disk disease at up to 30 clinical trial sites across the U.S. once it is fully enrolled.
"We are pleased to announce enrollment of the first patients in our IDE study in TLIF procedures," said Glen Kashuba, chief executive officer of Cerapedics. "More than 300,000 people in the U.S. suffer from degenerative disk disease that leads to pain and nerve irritation and often requires surgery. Our first-generation bone graft is already approved for anterior cervical discectomy and fusion (ACDF) procedures, and this pivotal study in TLIF procedures will be instrumental in a second Premarket Approval (PMA) application for our next-generation P-15 technology in the years ahead."
In TLIF procedures, surgeons historically obtained bone graft from the patient's pelvis and placed it in the interbody space to promote fusion when joining and stabilizing one or more vertebrae. P-15L Bone Graft is based on a biomimetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attraction, attachment, and activation, and is designed to be used as a substitute for autologous bone. In 2015, the company's first-generation bone graft became the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine.
"This important first patient enrolled signifies the culmination of substantial efforts on the part of many external and internal collaborators," said Jeffrey G. Marx, Ph.D., president and chief operating officer of Cerapedics. "We are grateful for all of the efforts that have gotten us to this point and are excited about the future of this study and the P-15L Bone Graft technology. We would like to give special thanks to Dr. Small and his clinical research team for enrolling the first patient."
"The team at the Foundation for Orthopaedic Research and Education is pleased to participate in this important IDE trial of P-15L Bone Graft. Being involved in the study of a new drug-device combination product for spinal fusion is gratifying. We look forward to this first step in potentially expanding the indications for use of peptide enhanced bone grafts to the lumbar spine," said Dr. John M. Small, M.D., of Tampa, Florida.
Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.
CAUTION: P-15L Bone Graft is an Investigational Product limited by Federal (USA) Law to Investigational Use.
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