August 2016 – Page 3

INCLINE VILLAGE, Nev., Aug. 29, 2016 /PRNewswire/ — PDL BioPharma, Inc. (NASDAQ: PDLI) (PDL or the Company) today announced that PDL has received approximately $57.4 million in connection with the termination of PDL’s credit agreement with Paradigm Spine, LLC, which included a repayment of the full principal amount outstanding of $54.7 million as well as accrued interest and a prepayment fee. In February 2014, PDL entered into a credit agreement with Paradigm Spine in which it made available up to $75.0 million of debt financing with a five-year term, and initially provided $50.0 million, net of fees. PDL subsequently provided an additional $4.0 million in October 2015 as part of an amendment to the credit agreement.

“We are pleased with the successful conclusion of our debt financing to Paradigm Spine and the return on investment it has generated for PDL. This marks the fifth matured investment of the 17 income generating asset transactions we have entered into since we began these efforts in mid-2012,” stated John P. McLaughlin, president and chief executive officer of PDL. “We congratulate Paradigm Spine on their commercial progress and thank them for the opportunity to partner with them by offering debt financing to support their commercialization efforts.”

About PDL BioPharma, Inc.

PDL seeks to acquire pharmaceutical products through equity investments and also provide growth capital and financing solutions to late-stage public and private healthcare companies, including immediate financial monetization of royalty streams to companies, academic institutions, and inventors. PDL has committed over $1.4 billion and funded approximately $1.1 billion in these investments to date. PDL evaluates its investments based on the quality of the income generating assets and potential returns on investment. PDL is currently focused on acquiring and managing income generating assets, and maximizing value for its stockholders.

The Company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it receives significant royalty revenue.

PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.

Logo – http://photos.prnewswire.com/prnh/20110822/SF55808LOGO

SOURCE PDL BioPharma, Inc.

FARMINGDALE, N.Y., Aug. 29, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, announced that, effective September 2, 2016, Michael A. McManus, Jr. is resigning as a Director and Chairman of the Board of Directors of Misonix and retiring as the Company’s President and Chief Executive Officer.

Effective September 2, 2016, Stavros G. Vizirgianakis, a member of the Misonix Board of Directors, will serve, on an unpaid basis, as Misonix’s interim Chief Executive Officer. Misonix and Mr. Vizirgianakis are in negotiations for him to accept employment as Misonix’s full-time Chief Executive Officer.

Mr. Vizirgianakis has served on the Misonix Board since May 2013. He holds a 5.7% ownership stake in Misonix. He has been involved with Misonix as early as September 2010 as the owner of a company acting as Misonix’s South African distributor.

Mr. Vizirgianakis said, “I am honored to be asked to serve as interim Chief Executive Officer and am excited about the Company’s products and future. The Misonix team will no doubt continue to put forth their best efforts to design, develop and manufacture cutting-edge technology for the medical device field.”

Mr. McManus commented, “After 16 years as CEO, I retire with gratitude for the dedicated professionals who have contributed to the Company’s innovation and growth, and with great confidence in the Company’s future potential and the leadership ofStavros Vizirgianakis. I look forward to doing whatever I can to be helpful to him as he transitions to his new role.”

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact	Investor Contact
Misonix Contact:	Joe Diaz
Richard Zaremba	Lytham Partners
631-694-9555	602-889-9700
invest@misonix.com	info@misonix.com

Logo – http://photos.prnewswire.com/prnh/20160201/328020LOGO

SOURCE Misonix, Inc.

Related Links

http://www.misonix.com

By Zachary Brennan – August 23, 2016

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Under the new draft agreement, which is part of the fourth reauthorization of the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the addition of 20 full time employees (FTEs) to establish a new quality management framework, and $30 million to implement a system that improves the quality of real-world evidence (RWE) and linkages among data sources to enable greater use of RWE in the premarket setting.

Other initiatives outlined in the last reauthorization meeting held with industry in May include:

$12 million to strengthen the Third Party Premarket Review program
$8.5 million to improve employee retention through incentive pay for managers using existing authorities and policies
$6 million for an independent assessment of the review process, including a more complete assessment of MDUFA III improvements and outcomes
Funding for 36 to 43 FTEs to hire reviewers to increase premarket review capacity
Funding for 34 to 44 FTEs and $3 million to improve the pre-submission process and provide written feedback on 80 to 85% of pre-submissions (depending on number of FTEs supported) within 70 days or 5 calendar days prior to the meeting, whichever comes sooner
Funding for 28 to 38 FTEs and $1 million to complete 70% of de novo submissions within 120 to 150 days (depending on number of FTEs supported and assuming a workload of 50 de novo submissions per year, which is lower than the assumptions for previous proposals)
$4.5 million for the development of the my Devices submission and tracking portal
An unspecified amount of funding for 20 FTEs to hire additional supervisors to reduce the ratio of supervisors to reviewers, thus increasing the capacity of branch chiefs to provide greater oversight and ensure consistency of review procedures
$4 million to implement more effective recruitment and hiring
Funding for 13 FTEs and $3.6 million to provide for consistent review of software, streamlining and aligning FDA review processes with software lifecycles, continued engagement in international harmonization efforts related to software review, and other activities related to digital health
Funding for three FTEs to establish central program management for CLIA Waiver by Application submissions, with an option to fund an additional two FTEs plus $1 million in special operating costs to complete 90% of stand-alone CLIA Waiver applications that do not have a panel meeting in 180 to 150 days (depending on number of FTEs supported), 90% of Dual 510(k) and CLIA Waiver applications in 210 to 200 days, and 90% of stand-alone CLIA Waiver applications that have a panel meeting in 330 to 320 days (pending the review of potential legal impediments)
Funding for 12 FTEs and $3.5 million to develop internal FDA expertise on patient engagement, support the increased use of patient preference information (PPI) and patient reported outcomes (PROs) in premarket submissions, outline a flexible framework for PRO validation, and clarify the optional use of PROs
Funding for five FTEs and $2.45 million to establish a conformance assessment program for certified testing laboratories who evaluate medical devices according to certain FDA-recognized standards

READ THE REST HERE

Ness Ziona, Israel, August 17, 2016 – CollPlant Ltd. (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced positive final extended clinical trial results for Vergenix™STR for the treatment of tendinopathy. The Company anticipates receiving CE mark approval for Vergenix™STR in the third quarter of 2016.

The prospective, open label, single-arm trial was conducted at three leading Israeli hospitals (Meir Medical Center, Assaf Harofeh Medical Center and Hadassah Hospital), and the trial’s objective was to demonstrate the safety and performance of Vergenix™STR in 40 patients suffering from inflammation of the elbow tendon, commonly referred to as tennis elbow. All patients were followed for a total of six months after a single treatment. Product performance was assessed by measuring reduction in pain and recovery of motion, as reported by the specific Patient Related Tennis Elbow Evaluation questionnaire (“PRTEE”).

At three months following treatment, Vergenix™STR patients (N=39) reported an average PRTEE score improvement of 51% over baseline. At six-month follow-up, Vergenix™STR patients (N=36) reported a mean PRTEE score improvement of 59% over baseline.

The performance of Vergenix™STR also compared favorably to published results of corticosteroid injection, which is the standard-of-care therapy for tennis elbow (1) . At three months following treatment, 74% of Vergenix™STR patients reported a 25% or better PRTEE score improvement while, in the published controlled trial, 48% of steroid patients showed at least a 25% reduction in pain and disability(2) . Further, at six month follow-up, 86% of Vergenix™STR patients reported a 25% or better PRTEE score improvement, while 36% of steroid patients showed at least a 25% reduction in pain and disability.

An additional analysis utilizing a threshold of at least 50% improvement in PRTEE score showed that at three months following treatment, 62% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score while, in the published controlled trial, 33% of steroid patients had at least a 50% reduction in pain and disability (3) . At six month follow-up, 64% of Vergenix™STR patients showed at least a 50% improvement in PRTEE score, while 17% of steroid patients showed at least a 50 % reduction in pain and disability.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, “We are very pleased with the final extended trial results, which we believe illustrate the significant potential advantages of Vergenix™STR over steroids, which are traditionally used as first line treatment for tendinopathy patients. CollPlant is making substantial progress towards commercialization, and we look forward to receiving CE Mark approval later this quarter, and making Vergenix™STR available to patients as soon as possible.”

About Vergenix™STR

Vergenix™STR, intended for the treatment of a range of tendon injuries, incorporates CollPlant’s recombinant human collagen in combination with platelet-rich plasma (PRP) derived from the patient’s blood. Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon, it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based rhCollagen technology for the development and commercialization of tissue repair products, initially for the orthobiologics and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary recombinant human collagen (rhCollagen), among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix™STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; Vergenix™FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds, and; Vergenix™BVF (Bone Void Filler), for use in spinal fusion procedures and trauma. CollPlant’s business strategy includes proprietary development and manufacturing of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacturing and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:

Eran Rotem, Chief Financial Office, Tel: +972-73-2325600/612

Email: Eran@collplant.com

Contact at Rx Communications Group, LLC

Paula Schwartz (for US Investors)

Managing Director

Tel: 917-322-2216

Email: pschwartz@RxIR.com

August 29, 2016 – By Stewart Eisenhart, Emergo Group

Brazil’s medical device market regulator ANVISA will implement new rules for more efficient transfers of device registrations between Brazilian Registration Holders (BRH).

After Emergo first reported on ANVISA’s transfer rule change plans in July 2016, the regulator has now issued RDC 102/2016 that introduces official regulation on those changes, set for implementation on December 25, 2016.

“With these new rules, it will be possible to transfer a device registration in Brazil without the need to have a corporate relationship,” explains Luiz Levy, Director of QA/RA at Emergo’s office in Brasilia. Existing regulations allow such transfers only in limited cases such as mergers and acquisitions.

Key features of the new transfer rules

RDC 102/2016 lays out several top-level requirements to which BRHs must adhere for proper transfers of registrations:

The original registration holder must give contractual permission for transfer to the new holder
Transfers must be submitted for ANVISA approval within 180 days of agreement signings
Transfers do not require the consent of the device’s legal manufacturer—a distributor acting as a BRH could sell a registration to another distributor or BRH without notifying the device’s manufacturer
Transfers may be requested for devices already registered with ANVISA as well as for devices that have been submitted but not yet approved for registration
Transfers go into effect 90 days after publication in the Official Diary in order to ensure issues such as labeling and stock depletions are addressed

READ THE REST HERE

By Shaun Gallagher

WARSAW, Ind. — While Northern Indiana is known as the RV Capital of the world, just an hour south of us, the orthopedic industry could give the RV industry a run for its money.

“The local companies here generate $17 billion in revenue annually,” Sheryl Conley, President & CEO of Orthoworx said. “It has $5 billion of impact to the state of Indiana on very many economic levels. It is critical to us. it is an industry that’s continuing to grow.”

For this growing industry, dozens of legislators came to Warsaw to hear about the economic boom it provides for the state.

“It’s increasingly known as the orthopedic implant capital of the world,” Chris Cerone, VP of Global Government Affairs for Zimmer Biomet said. “It’s a tremendous American success story. I have an opportunity to travel to other countries and one of the best things I do is talk about Warsaw and it’s importance to patients, health care and the importance to the economy of both Warsaw the region and the state and the US economy as well.”

While the industry is booming in Indiana and the country, it’s also big internationally and Warsaw is globally recognized as the hub of orthopedics devices.

READ THE REST HERE

Written by Laura Dyrda

CMS is proposing to add eight spine codes to the list of ASC covered procedures in 2017, according to the International Society for the Advancement of Spine Surgery.

The eight procedures are:

1. Autograft for spine surgery (includes harvesting the graft); local (eg, ribs, spinous process or laminar fragments) obtained from the same incision (List separately in addition to code for primary procedure): 20936

2. Autograft for spine surgery only (includes harvesting the graft); morselized (through separate skin or fascial incision) (List separately in addition to code for primary procedure): 20937

READ THE REST AT BECKER’S

By STEPHEN MATTHEWS FOR MAILONLINE

A toddler with a crooked spine must wear a special cast for 24 hours a day to prevent his lungs from being crushed.

Charlie Ferris can not even bathe while he wears the suit because water would prevent it from working properly.

The 13-month-old, from County Tyrone, Northern Ireland, has scoliosis – twisting of the spine – which if left untreated could kill him.

His family were told he would need to wear a plaster jacket for four months to stop the curve from becoming worse.

But after scans revealed his condition was deteriorating rapidly, his alarmed parents travelled to the US for a special cast which moulds his spine back into shape – in an attempt to save his life.

‘But I didn’t care how much it cost. We’d live in a tent if needs be to pay for the treatment and getting there. I was prepared to move.’

They first noticed Charlie’s back was twisted in October 2015 after his father Jody, 36, noticed an abnormal bend.

After an X-ray at Belfast’s Musgrave Park Hospital, he was officially diagnosed with infantile scoliosis and doctors confirmed he had a 28° curvature.

Written by Megan Wood

Neurosurgeon Mick Perez-Cruet, MD, of Southfield-based Michigan Head & Spine Institute, offers his insight on minimally invasive spine surgery, value-based care and what the future holds for outpatient spine.

Question: What are the opportunities and challenges in MIS spine today?

Dr. Mick Perez-Cruet: I think the biggest opportunity is patients’ desire for these MIS spinal procedures. Patients seek out surgeons who know how to apply them effectively and proficiently. They are often concerned about having spine surgery, yet they want to eliminate their painful symptoms and disability while recovering quickly and returning to a fully functional active lifestyle. MIS procedures provide these opportunities to our patients. Patients are also looking for MIS procedures that don’t lead to multiple re-do operations.

The biggest challenge is the transition from traditional spine surgery to minimally invasive approaches. The technology has to catch up to provide the opportunity for surgeons who are not familiar with these techniques to perform them safely, effectively and proficiently. Surgeon-led technology development can help make this a reality.

I think another big challenge is the understanding of the pathophysiology of spinal disorders. Don’t treat the X-ray, treat the underlying problem, or underlying pathophysiology, causing the individual patient’s symptoms. Patient spine care should not be focused on making the X-ray look good, but rather try to make the patient feel great and return to an active lifestyle. This is a challenge that will require a better understanding of spinal disorders so that clinician can provide focused cost-effective MIS spine care that results in long-term excellent patient outcomes.

Q: How does MIS spine surgery fit into value-based care?

READ THE REST HERE

August 23, 2016

MAYWOOD, IL – A surgery for quadriplegics called tendon transfer can significantly improve hand and elbow function, but the procedure is greatly underused, according to an article in the journal Hand Clinics by Loyola Medicine hand surgeon Michael S. Bednar, MD, FAAOS.

In the procedure, muscles that still work are redirected to do the jobs of muscles that are paralyzed. Depending on the extent of the spinal cord injury, tendon transfers can enable a patient to grasp objects, pinch, open the hand and straighten the elbow. The patient can, for example, propel a wheelchair in the snow, use a fork without splints, grip a fishing pole, shake hands and perform daily activities such as dressing, bathing, toileting and transferring to and from a wheelchair.

“Although the long-term outcomes of these procedures are good, few patients eligible for these procedures actually have them performed,” Dr. Bednar wrote.

Dr. Bednar has performed tendon transfers on about 60 patients, and is among the most skilled and experienced surgeons in the country doing the procedure. Dr. Bednar is a professor in the department of orthopaedic surgery and rehabilitation at Loyola University Chicago Stritch School of Medicine.

When quadriplegics were asked what function they would most like restored, 75 percent said hand function, followed in order by bowel and bladder use (13 percent), walking (8 percent) and sexual performance (3 percent), according to an earlier study cited in Dr. Bednar’s article. However, only 14 percent of patients who are surgical candidates wind up getting tendon transfers, according to another previous study.

Patients who stand to benefit most from tendon transfers have spinal cord injuries in the C5-C8 cervical nerves in the lower neck. Patients must not have acute or chronic medical conditions such as infections, pressure sores, medical instability or spasticity.

“A good surgical candidate has functional goals, is motivated, understands benefits and limitations of surgery, demonstrates emotional and psychological stability/adjustment to disability and is committed to the post-operative rehabilitation process,” Dr. Bednar wrote.

Skeletal muscles come in pairs – one muscle to move the bone in one direction, another muscle to move it back. Muscles are connected to bones by tendons. The bone moves when the brain sends a signal down a nerve telling the muscle to contract.

In many cases, more than one muscle performs the same function. So in a tendon transfer, the surgeon shifts the tendon of one of the spare muscles to a new location. For example, the surgeon may detach one of the working elbow muscles (the brachioradialis) and reattach it to a nonworking muscle that flexes the thumb (the flexor pollicis longus).

The number of functioning muscles a patient has will determine what tendon transfers the surgeon will perform. The more working muscles available for transfer, the more functions can be restored.

Tendon transfers typically involve two surgeries on each arm, performed three months apart. Arms are done one at a time. During rehabilitation, patients learn how to use the transferred muscles.

Tendon transfers temporarily reduce hand and elbow function during recovery and rehabilitation. Tendon transfers also do not restore full function. But while pinch strength and grasp strength after rehabilitation are not as high as in a normal hand, they are high enough to perform most activities of daily living.

Among the reasons so few patients get tendon transfers are lack of communication among rehabilitation specialists, physicians and surgeons, poor access to care and lack of awareness. The greatest barrier appears to be a lack of coordinated collaboration among specialists, Dr. Bednar wrote.

Dr. Bednar concluded: “Continued education of patients with tetraplegia, their caregivers and the rehabilitation community will hopefully increase utilization of these effective tendon transfer procedures.” (Tetraplegia is another term for quadriplegia.)

Dr. Bednar’s paper is titled “Tendon Transfers for Tetraplegia.”

– Loyola University Health System

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Current Issues in Spine

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