SpinalCyte, LLC Enrolls First Patient in Landmark Phase I Human Clinical Trial

Posted On January 27, 2017 By OrthoSpineNews In Spine /

January 26, 2017

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on the regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the enrollment of its first patient in a study for the development of CybroCell, the first dermal fibroblast cell product for treatment of degenerative disc disease.

“This unprecedented study marks the first time a human patient will receive dermal fibroblasts for treatment of degenerative disc disease,” said SpinalCyte Chief Executive Officer Pete O’Heeron. “Our preclinical trials resulted in significant regrowth of the spinal disc nucleus, increases in disc height, and gene expression such as proteoglycan. This could be the beginning of a new wave of cell-based treatments for degenerative disc disease, in lieu of surgery.”

The clinical trial will enroll 18 patients between the ages of 18 and 85. Each patient will be administered CybroCell alone, in combination with platelet-rich plasma (PRP), or saline only. The measurable outcomes of the study will take 12 months. SpinalCyte aims to show that using its allogenic “prepackaged” cell therapy product will lead to a reduction in pain, improved function, and regeneration of damaged discs.

“We are excited about the potential of this new technology to treat degenerative disc disease,” said Carlos Manuel Ruiz Macias, M.D., Principal Investigator of the SpinalCyte clinical trials. “We believe that regenerative cell therapy is the future of medicine, and the life-changing opportunities that lie ahead could have enormous impact on the millions around the world who deal with back pain and problems due to injury, age, or other factors.”

To learn more about SpinalCyte, LLC, please visit www.spinalcyte.com.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 12 U.S. and international issued patents, and has filed for an additional 40 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

Investor Contact:
SpinalCyte, LLC
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com
or
Media Contact:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

Alphabet’s life science spinoff raises $800M from Singapore investor

Posted On January 27, 2017 By OrthoSpineNews In Financial /

Luke Stangel, Contributing writer – Jan 26, 2017

Verily Life Sciences, one of the startups spun out of Alphabet, disclosed on Thursday it has closed an $800 million investment from Singapore-based Temasek, an investment company that recently landed in the Bay Area with plans to expand its holdings in North America.

Verily, previously known as Google Life Sciences, says it’ll get the majority of the money in the coming days, with the remainder coming later this year. Temasek will take a minority stake in the company and get a seat on Verily’s board.

The investment marks Alphabet’s latest attempt to reduce the financial risk inherent in its more experimental business units like Verily. In the past, a spinoff like Verily might have instead asked its corporate parent for the investment.

Around this time last year, Verily partnered with Johnson & Johnson to create a new robotic surgery startup called Verb. A few months later, it announced a $715 million joint venture with Glaxosmithkline to create a new bioelectronics medicine company called Galvani Bioelectronics. In September, Verily announced it was creating a $500 million joint venture with Sanofi called Onduo.

READ THE REST HERE

RTI Surgical Names Camille Farhat Chief Executive Officer

Posted On January 27, 2017 By OrthoSpineNews In Biologics /

ALACHUA, Fla.–(BUSINESS WIRE)– January 26, 2017

RTI Surgical Inc. (“RTI” or “the company”) (RTIX), a leading global surgical implant company, today announced that Camille Farhat has been named chief executive officer, effective March 15, 2017. He will succeed interim chief executive officer, Robert P. Jordheim, who will resume his role as chief financial officer.

Mr. Farhat, 47, previously served as president and CEO of American Medical Systems, Inc. (AMS), an operating business of Endo International plc (NASDAQ/TSX: ENDP). In this role, he realigned the business to fund innovation, expand internationally and resume growth, ultimately leading to Boston Scientific’s $1.65 billion acquisition of the Men’s and Prostate Health businesses. Mr. Farhat’s expertise aligns with RTI’s focus on developing and delivering exceptional products for patients and achieving sustainable, long-term growth. He has a track record of revitalizing and profitably growing global businesses within the health care industry. Prior to AMS, Mr. Farhat held senior leadership roles where he improved the performance of business units at companies including Baxter Healthcare, Medtronic, Inc. and General Electric.

“Today marks a significant development for RTI’s future. We are pleased that Camille Farhat, an experienced leader with a laser customer focus and solid track record of driving highly effective operational performance in complex health care markets, has agreed to join RTI as our new CEO,” said RTI Chairman Curtis M. Selquist. “On behalf of the entire board, I would like to thank Robert Jordheim for his service as interim CEO. We are pleased that he will be returning to his role as our chief financial officer once Camille is on board. I also want to thank Wy Louw, who has been serving as interim CFO and will resume his controller responsibilities.”

Nicholas J. Valeriani, the RTI board member who led the CEO search process, added, “Following a broad search of both internal and external candidates by RTI’s independent directors, we are confident that Camille has the discipline, talent and demonstrated ability to lead RTI to future success. The company and our customers will benefit from his vibrant leadership, dedication to patients, demand for strategic and operational excellence, and persistent dedication to getting things done and achieving sustainable, long-term growth.”

Mr. Farhat has broad global leadership experience, with senior-level assignments in 10 countries during the past 22 years. Prior to AMS, he advanced several business segments for Baxter. He was global general manager of Baxter’s largest division, Baxter Pharmaceuticals and Therapies, where he drove significant improvements in the performance and operating efficiency of the business, helping to transform it into Baxter’s top-performing business unit. In a previous role, Mr. Farhat successfully turned around Baxter’s Global Infusion Systems business division under a consent decree. Mr. Farhat also served as vice president of business development at Medtronic and as global general manager of the company’s Gastroenterology and Urology divisions. Earlier in his career, Mr. Farhat gained broad executive experience at GE with roles in multiple businesses, geographies and functional areas, leading to his last role as general manager of GE Healthcare’s global Computed Tomography business.

“I am excited to have the opportunity to shape RTI’s strategic direction and return it to sustainable growth,” said Mr. Farhat. “The RTI leadership team, its talented employees and I will dedicate ourselves to developing successful strategies for each business area to ensure we are better addressing our patients’ critical needs and leading the industry in innovation and quality. In doing so, I am confident that we will advance RTI’s path to growth and success.”

Mr. Farhat earned an M.B.A. from Harvard University, a degree in European Union studies from Institut National d’Etudes Politiques de Paris and a B.S., B.A. in finance and accounting from Northeastern University.

RTI’s board worked with Spencer Stuart on the search process.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170126005306/en/

Ortho Sales Partners Adds Supply Chain and Logistics Executive to its Leadership Team

Posted On January 27, 2017 By OrthoSpineNews In Recon, Spine /

SCOTTSDALE, ARIZONA (PRWEB) JANUARY 27, 2017

Ortho Sales Partners, a professional consulting firm focused on assisting orthopedic and spine implant manufacturers in the commercialization of their products, announces the addition of Tony Passalacqua to their executive team, effective January 25, 2017. Mr. Passalacqua brings extensive experience to Ortho Sales Partners and will focus primarily on working with clients to optimize their sales operations by improving inventory management and utilization of costly instrument sets.

Mr. Passalacqua brings with him more than 27 years of supply chain and operational experience most recently serving as Vice President of Operations for an orthopedic distributorship that saw growth from approximately $20M to over $120M during his 10-year tenure. His primary responsibility was to create a scalable infrastructure, seamlessly on-board new product lines and categories, manage surgery schedules and recruit personnel to support an organization that was routinely participating in as many as 50 surgeries per day.

With a career that began in the United States Navy, Mr. Passalacqua earned his Bachelor of Science in Management from Arizona State University. He joined FedEx Ground where he led one of the largest and most profitable operations in the FedEx network. After 11 years at FedEx, Mr. Passalacqua joined Stryker Orthopaedics to transform the way they managed inventory in the field. He was responsible for facilities throughout the southwest including: California, Arizona, Nevada, Utah, Colorado and New Mexico.

“We are thrilled to have someone with Tony’s knowledge and experience join Ortho Sales Partners,” said Josh Sandberg. Co-Founder & General Manager. “Our mission is to help companies solve complex problems by leveraging our partners’ vast experiences and mitigate the risks associated with early market entry and commercialization. Tony will provide immense value to our clients and brings a skillset that few have in our industry.”

Regarding his new role, Mr. Passalacqua said: “It’s an honor to join an organization whose purpose and mission is to help people and companies grow their business. The unique challenges of the orthopedic industry and the ever changing landscape is an exciting problem to solve.”
_________

About Ortho Sales Partners – Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
OUS companies looking to establish or enhance their presence in the United States.
Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
Established companies looking for marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis rather than surgery volumes from over 4 years ago.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US.
http://www.orthosalespartners.com

FDA SPEEDS UP DEVICE RECALL POSTINGS

Posted On January 27, 2017 By OrthoSpineNews In Regulatory /

January 26th, 2017 – By Walter Eisner

The public is going to get information on recalled medical devices a little quicker in 2017. The FDA announced on January 3, 2017 that the agency is posting device recall information on its website earlier than in previous years.

The FDA used to post device recall information only after the agency announced the company’s initiation of a correction or removal action. Now, the agency is posting the information on the Center for Devices and Radiological Health’s (CDRH) Medical Device Recalls Database at the time the company takes a correction or removal action and notifies FDA that it can post the information, rather than at the time of FDA’s recall classification.

Click here to go to the agency’s recall page.

So far, there has only been one recall in 2017. Nurse Assist Inc. recalled the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.

The FDA issued 39 device recalls in 2016, which was more than the 32 recalls from 2015 but significantly less than the 60 recalls from 2014.

READ THE REST HERE

Stryker Maintains Growth Momentum With Strategic M&A, Robotic Surgery Roll-Out

Posted On January 27, 2017 By OrthoSpineNews In Financial /

January 26, 2017 – By Suzanne Hodsden

Stryker Corporation delivered its fourteenth straight quarter with double-digit growth in net sales in 2016’s fourth quarter, building on the rest of the year’s momentum and staggered roll-out of MAKO surgical robots, said CEO Kevin Lobo. Despite its pair of billion-dollar acquisitions — Sage Products and Physio-Control — Lobo said Stryker is “actively” seeking new strategic growth through acquisitions.

Despite “tough” year-over-year comparisons, Lobo reported in an earnings call that Q4 represented 2016’s highest growth quarter, with 16.2 percent growth across all of Stryker’s core businesses: orthopedics, medsurg, and neurotechnology and spine. The company experienced its largest sales bump in medsurg, with a staggering 31 percent for the quarter.

Earlier in 2016, Stryker completed a series of acquisitions, including a $2.78 billion deal for Sage Products — manufacturer of disposable hospital supplies designed to prevent hospital-related infections — and a $1.28 billion deal for Physio-Control, with its portfolio of emergency services equipment. Despite heavy R&D investment in both segments, the two acquisitions delivered 11.8 percent and 7.4 percent Q4 growth, respectively.

“We continue to complete value creating acquisitions, our globalization efforts are bearing fruit, and we are also building capability to deliver consistent leveraged earnings,” said Lobo.

Moving forward, Lobo said that he has not ruled out further investment and growth opportunities, and that the volume of M&A activity in 2016 is not indicative of a slowdown in 2017. While certain segments took on the job of the two large acquisitions, other divisions “certainly have the bandwidth” to accommodate additional deals.

READ THE REST HERE

VTI ADDS PATENT FOR ITS MODULAR MOTION PRESERVATION SPINAL IMPLANT

Posted On January 27, 2017 By OrthoSpineNews In Regulatory, Spine /

Minneapolis, MN – VTI, a MIS medical device company focused on lumber spine solutions, announced today that it has been granted a new patent from the U.S. Patent and Trademark Office. This patent relates to the company’s unique modular, in vivo assembly technology and its motion preservation, InterCushion® pipeline product. VTI now has over 25 patents and patent pending assets in its global intellectual property portfolio.

“The grant of this patent expands and lengthens VTI’s protection of our unique in vivo expansion technology for minimally invasive lumbar spine solutions. VTI is a world leader in lumbar spine focused motion preservation/disc nucleus replacement technology. This patent exemplifies our continued commitment to protect and broaden our intellectual property portfolio in this space. We are encouraged by the clinical results we are seeing from clinical trials using VTI’s modular technology in our InterCushion® product line,” commented Matthew R Kyle, President and CEO of VTI.

VTI’s InterCushion® lumbar spine motion preservation product has been successful in reducing pain, preserving disc, and halting modic changes in clinical trials in Canada. Currently, several patients are at or near 5 years’ post implantation with continued clinically successful outcomes.

Dr. Philip de Muelenaere stated “The potential value of an intervertebral nucleus replacement is linked to decreased future deterioration of the spinal motion segment. By maintaining disc height, the motion is maintained, stability is regained and long term collapse prevented. This protects the patency of the foramina, and decreases facet arthrosis which, apart from being a pain generator, will compromise the exiting nerve root.

The 5 year follow up MRI study proves that the prosthesis had maintained its position, maintained the disc height and kept the patients pain free.”

ABOUT VERTEBRAL TECHNOLOGIES, INC.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells InterFuse® modular interbody fusion devices worldwide.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.952-979-1811

Minimally invasive surgery “markedly reduces” postoperative infection risk

Posted On January 26, 2017 By OrthoSpineNews In Spine /

26th January 2017

Minimally invasive surgery is generally considered to reduce blood loss and preserve surrounding tissue, among other benefits. There is a dearth in the literature, however, on the association between minimally invasive techniques and surgical site infections.

Research published in the Asian Spine Journal has found very low rates of postoperative infection following minimally invasive spinal surgery in comparison to open surgery.

“One of the worst complications of any orthopaedic or spinal operation is surgical site infection,which can have devastating consequences,” lead author Arvind Kulkarni told Spinal News International. “Hypothetically, it appears that the incidence of surgical site infection should be minimal in minimally invasive surgery compared to open surgery—the reasons being lesser soft tissue dissection, lesser destruction of tissues, lesser exposure of surface area to pathogens etc.”

Records from 1,043 patients (52% male, 48% female; 52.2 years average age) undergoing tubular discectomies, decompressions and transforaminal interbody fusions at the Bombay Hospital and Medical Research Centre in Mumbai, India, from January 2007 to January 2015 were used to find the frequency of surgical site infection over the 12 months following each procedure.

READ THE REST HERE

Early data demonstrate motor function improvement for spinal cord stem cell treatment

Posted On January 26, 2017 By OrthoSpineNews In Biologics, Neuro /

26th January 2017

A new therapy to treat spinal cord injuries in people who have lost all motor and sensory function below the injury site has shown additional motor function improvement at six-months and nine-months following treatment with 10 million AST-OPC1. The positive efficacy results from an ongoing clinical research study were revealed in a conference held by Asterias Biotherapeutics, the biotechnology company manufacturing AST-OPC1.

AST-OPC1 cells are made from embryonic stem cells by carefully converting them into oligodendrocyte progenitor cells, which are cells found in the brain and spinal cord that support the healthy functioning of nerve cells and can potentially make poorly functioning nerves function better.

“With these patients, we are seeing what we believe are meaningful improvements in their ability to use their arms, hands and fingers at six months and nine months following AST-OPC1 administration,” says Richard G Fessler, professor in the department of neurosurgery at Rush University Medical Center and lead investigator in the SCiStar Phase 1/2a study. Rush is one of six centres in the country currently studying this new approach.

A total of six patients were enrolled and treated with 10 million AST-OPC1 cells, with five of six patients having now completed a six-month follow-up, and three of six patients having completed a nine-month follow-up.

“Recovery of upper extremity motor function is critically important to patients with complete cervical spinal cord injuries, since this can dramatically improve quality of life and their ability to live independently,” says Fessler.

In September 2016, Fessler reported positive early efficacy data for AST-OPC1 from the patients who have lost all motor and sensory function below injury site that had been treated with 10 million AST-OPC1 cells in the study. The interim research results were announced at the 55th annual Scientific Meeting of the International Spinal Cord Society (ISCOS; 4-16 September 2016, Vienna, Austria).

“We look forward to initiating discussions with the FDA in mid-2017 to begin to determine the most appropriate clinical and regulatory path forward for this innovative therapy,” says Steve Cartt, chief executive officer of Asterias.

READ THE REST HERE

DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems

Posted On January 26, 2017 By OrthoSpineNews In Regulatory, Spine /

RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER^® and EXPEDIUM^®Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.

Metastatic spine disease accounts for 10 percent to 30 percent of new cancer diagnoses annually.¹ Surgical fixation with pedicle screws may be used as palliative care to stabilize the spine, help reduce pain and help keep the patient mobile.¹The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with holes called fenestrations above the screw tip enable controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation.

“Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely,” said William C. Horton, M.D., Vice President of Research & Development, DePuy Synthes Spine. “We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease.”

The VIPER Fenestrated Screws are compatible with the VIPER and EXPEDIUM 5.5 Spine Systems and the EXPEDIUM Fenestrated Screws are compatible with the EXPEDIUM VERSE Spinal System. Both fenestrated screw systems are anticipated to be available in the United States in mid-2017.

Indications for Use

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER^® and EXPEDIUM^® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER^® and EXPEDIUM^® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International, SARL is the legal manufacturer of the VIPER and EXPEDIUM Fenestrated Screw Systems.

DSUS/SPN/0117/1510 01/17

¹ Dunning, E.C, et al. Complications in the management of metastatic spinal disease. World J Orthop. 2012 Aug 18; 3(8): 114–121.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/depuy-synthes-receives-fda-clearance-for-cement-augmented-pedicle-screw-systems-300397372.html

Month: January 2017

Contacts

January 26th, 2017 – By Walter Eisner