HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announces the initiation of the SIMPACT Sacroiliac Joint (SI) Fixation Outcomes Study, with Dr. Keith Maxwell of Southeastern Sports Medicine and Orthopedics in Asheville, North Carolina.
SIMPACT is a cannulated and fenestrated screw, intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis through a lateral approach. SIMPACT also incorporates the proprietary surface technology OSSEO-LOC™, and is available in multiple lengths to accommodate varying patient anatomy.
Mariusz Knap, Vice President of Marketing and Business Development for Life Spine said: “SIMPACT joins our recently released PROLIFT® Expandable Outcomes Study, further demonstrating our commitment to providing robust investment into clinical studies which evaluate the safety and efficacy of our products. As well as adding to the body of data validating our state-of-the-art product offering, these studies will demonstrate possible medical economic savings and highlight other advantages associated with new technologies such as SIMPACT.”
Dr. Keith Maxwell who is the principal investigator for the study notes, “With more than 22% of lower back pain originating from the sacroiliac joint1, the market for SI joint fixation continues to grow as better diagnostic tools and better understanding of the pathology evolve. SIMPACT has streamlined the SI joint fixation procedure for me and my patients by creating a screw design that is self-drilling, resulting in fewer surgical steps. I continue to see excellent results in treating sacroiliac joint disruptions and degenerative sacroiliitis, and we expect these results to continue throughout the course of this study.”
About Life Spine
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit http://www.lifespine.com.
1.Bernard et al. Recognizing specific characteristics of non-specific low back pain. Clinical Orthopedics and Related Research. April 1987; 217:266-280
MISSION VIEJO, Calif., Feb. 14, 2019 /PRNewswire-PRWeb/ — Innovasive, a privately-held spinal device company that focuses on developing and commercializing minimally-invasive, innovative spinal technologies, today announced a corporate rebrand and name change to Amplify Surgical, Inc.
“The Amplify Surgical name better emphasizes our commitment to delivering new, cutting-edge, surgical solutions that reestablish the standard of care for our surgeon customers and their patients,” explained Andy Choi, Chief Executive Officer, Innovasive, Inc. “In addition, the new name and brand better represents the Company’s inventive culture and product pipeline.”
In October 2018, the Company received U.S. Food and Drug Administration (FDA) clearance for its first product, dualX – the Dual Expanding Interbody Fusion System. DualX is comprised of a family of titanium expandable interbody devices designed to be used in transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and lateral lumbar interbody fusion (LLIF) spinal procedures. The product portfolio contains varying footprints, heights and degrees of lordosis with post-expansion bone grafting to provide a customized, anatomical fit for a clinically-successful fusion environment.
The Company officially changed its name in January and has begun the rebranding process. The Company anticipates the rebranding process will continue through the end of the first quarter.
About Amplify Surgical Amplify Surgical, Inc. is a privately-held spinal device company located in Mission Viejo, CA. The Company focuses on developing and commercializing innovative, minimally-invasive technologies for spine surgery. Amplify Surgical is a portfolio company of IntuitiveX, a life science innovation incubator.
Formal meeting with FDA later this month to formalize path to initiate human trials on Ortho-R.
KIRKLAND, QC, Feb. 11, 2019 /PRNewswire/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTi” or the “Company”), an emerging Orthopaedic and Sports Medicine Technology company, today announced the initiation of a 6-month pivotal animal study on Ortho-R for rotatorcuff repair. In addition, a pre-IND (Investigational New Drug) meeting is to be held later this month with the Food and Drug Administration (“FDA”) to formalize the requirements for the filing of its application to commence human trials on Ortho-R.
“The pivotal study is designed and powered to show statistically significant healing for rotator cuff repair by way of MRI and Histopathology. The first series of MRI results will be available after 3 months and are expected to confirm our previous findings where we showed superior healing over standard of care. The study is also designed to assess whether the repair could be accelerated or further improved with a higher dose of Ortho-R”, said Ortho RTi’s Chief Scientific Officer, Dr. Michael Buschmann. “We had excellent results in our initial preclinical study, and it will be exciting to evaluate if more Ortho-R results in a further improved outcome”.
Ortho RTi recently compiled and submitted documents for a formal pre-IND submission meeting with the FDA. The purpose of the meeting is to discuss moving Ortho-R into the clinic for human testing. The results of this pivotal study on Ortho-R are intended to augment the IND package with more information on the ideal dosage to take forward into patients.
“2019 is already shaping up to be a transformational year for Ortho RTi. With the initiation of our pivotal study on Ortho-R and the pre-IND meeting a few weeks away, we are rapidly progressing towards demonstrating the clinical merits of using our lead biologic Ortho-R for rotator cuff repair”, said Dr. Brent Norton, Ortho RTi’s Chief Executive Officer.
About Rotator Cuff Injury
The rotator cuff is the name given to the collection of four tendons that stabilize the shoulder joint. The tendons around the joint can suffer tears as a result of injury to the tendon or as a result of degeneration over time. Repetitive overhead activity is often associated with cuff tears. Symptoms include a dull, aching pain, and patients often suffer secondary symptoms including lack of sleep and weakness in the arms resulting from a lack of exercise. If conservative therapy is not successful, surgery will often be performed. The principal aim of surgical intervention is to reattach the torn tendon to the bone. The standard of care involves the use of suture anchors placed into the bone and the tendon then being held in place with sutures. There are 4 million Americans with rotator cuff injuries, and all are at risk for disability. It is estimated that 25% of U.S. adults over the age of 40 will develop a rotator cuff tear, with aging ‘weekend warriors’ escalating the problem.
About Ortho Regenerative Technologies Inc.
Ortho RTi is an emerging Orthopaedic and Sports Medicine biologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to tendons, meniscus, ligaments and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Considering the significant bioactivity and residency of our proprietary biopolymer, Ortho RTicontinues to assess its potential for therapeutic uses outside of the soft tissue repair. Further information about Ortho RTi is available on the Company’s website at www.orthorti.com and on SEDAR at www.sedar.com.
This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.
Global partner to market an advanced bone graft supplied by Kuros
Agreement demonstrates interest of major orthobiologic companies in Kuros technologies
SCHLIEREN (ZURICH), Switzerland, Feb. 11, 2019 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) today announced that its Dutch subsidiary, Kuros Biosciences BV, has signed a private label Original Equipment Manufacturer (OEM) agreement with SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders. Under the agreement Kuros will supply the bone graft in various forms and SeaSpine will market the products under the brand name OsteoCurrent in the U.S. and other select markets in Europe, South America and the Middle East providing the necessary regulatory approvals are achieved. Initial sales in the U.S. are expected prior to the end of H1 2019. Terms of the agreement were not disclosed.
Kuros’s proprietary bone graft technology comprises biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique topography, it preferentially directs early wound healing toward the bone-forming pathway, resulting in predictable healing, reliable fusions and an osteoinductive claim in Europe.
Joost de Bruijn, Chief Executive Officer of Kuros, said “This is an important agreement, which demonstrates the interest of global orthobiologic companies in Kuros’s technologies and should allow greater penetration of our bone grafting technologies into the US, and other markets. We look forward to working together with SeaSpine to make OsteoCurrent a success and to improving the bone grafting options for surgeons.”
Keith Valentine, Chief Executive Officer of SeaSpine, said “We are excited to partner with Kuros to provide OsteoCurrent to our SeaSpine distributor partners, their surgeons and patients. We believe OsteoCurrent represents a best of class pure synthetic that will strengthen our product offering.”
About Kuros Biosciences AG Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.
About SeaSpine SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.
About OsteoCurrent The formal process of registering the OsteoCurrent name and product codes with appropriate regulatory authorities is now commencing with the expectations of the following indications: US indications statement: OsteoCurrent is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, OsteoCurrent must be used with autograft as bone graft extender. In extremities and pelvis, OsteoCurrent is used alone. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EU indications statement: OsteoCurrent is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. OsteoCurrent is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoCurrent is intended to be packed into bony voids or gaps of the skeletal system (i.e. extremities, spine, cranial, mandible, maxilla and pelvis) and may be combined with autogenous bone. OsteoCurrent should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, OsteoCurrent is to be used in conjunction with internal or external fixation devices.
Forward Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
Acquisition creates first company to offer product line for minimally invasive orthopedic diagnostics and surgical solutions
MALVERN, Pa.–(BUSINESS WIRE)–Trice Medical announced today that it is acquiring S.E.G-WAY™ Orthopaedics (SegWAY), a leader in solutions for minimally invasive orthopedic procedures. SegWAY is best known for its Endoscopic Carpal Tunnel Release (ECTR), a device that supports minimally invasive carpal tunnel surgeries. Trice Medical addresses the growing need for accurate, cost-effective orthopedic diagnostic solutions with its mi-eye™, a fully disposable arthroscopy camera.
“The SegWAY acquisition transforms Trice Medical into the first company that offers both minimally invasive orthopedic diagnostic and surgical solutions,” said Jeffrey O’Donnell Sr., CEO of Trice Medical. “We’re looking forward to integrating the SegWAY offerings and building on our combined strengths. One of the areas we’re looking at is using our minimally invasive camera technology in the operating room as well.”
“We’re excited for SegWAY to join forces with Trice,” added Stuart Seymour, CEO & Founder of SegWAY. “In just over five years, growing at 30 to 40 percent year-on-year, we’ve created tremendous traction among orthopedic surgeons. Teaming with Trice Medical, which is advancing technologies that involve cameras and ultrasound, rounds out our offering for those doctors.”
Mark Foster, President and CCO of Trice Medical, commented, “The combined Trice Medical and SegWAY capabilities will benefit surgeons and medical facilities in an efficient, cost-beneficial way. We believe we can solve big problems with small cameras, small instruments and minimal anesthesia for patients.”
More than 600,000 carpal tunnel surgeries are performed annually in the US, with about a quarter of them performed endoscopically. The SegWAY platform is also used in minimally invasive surgery for cubital tunnel syndrome, gastrocnemius equinus contracture and plantar fasciitis.
About Trice Medical:
Trice Medical was founded to fundamentally improve minimally invasive orthopedic diagnostics for the patient and physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology with the mi-eye 2™ and launched the world’s first Dynamic Imaging Platform combining a 15 MHz handheld ultrasound transducer with the mi-eye™ technology on one simple, portable platform. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reducing the overall cost to the healthcare system. To learn more visit www.tricemedical.com.