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Enrollment of the VasQ External Support US Pivotal Study Now Complete

Laminate Medical Technologies announced the completion of enrollment into the VasQ External Support US Pivotal Study.

The study was conducted at 17 sites across the U.S. and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for hemodialysis.  Both brachiocephalic and radiocephalic AVF patients were included in the study.  The patients will be followed for two years with the primary endpoint of primary patency analyzed at six months.

AVFs are the preferred vascular access to deliver hemodialysis treatment due to the low rates of infection and mortality relative to alternative options for patients.  However, the natural biologic responses to the changes in hemodynamics and mechanical stress at the vein wall from the arterial flow tends to induce in inward tissue growth and ultimately AVF failure.  Reported failure rates for AVFs are as high as 60% and require costly additional procedures to correct or a new AVF creation altogether.

VasQ is designed to address both the hemodynamic and mechanical factors associated with AVF failure.  The device is a nitinol external support placed around the artery and vein at the creation site that optimizes the transition of arterial flow to the vein while reinforcing the vessel wall against the increase in mechanical stress.  VasQ patients in Europe have demonstrated increased rates of receiving a usable AVF with fewer early failures and additional procedures in multiple prospective and retrospective studies.  The clinical benefits of VasQ experienced in Europe are expected to be validated in the US dialysis patient population within this fully enrolled pivotal study.

Prof. Ellen Dillavou, MD, FACS, of Duke University stated, “VasQ promises to be a new standard of care for fistula creation to give my hemodialysis patients the greatest probability of success.  The device has performed as expected in my study patients so far, and I look forward to continuing to utilize it once commercially available in the U.S.”

“We are grateful to our principle investigators for their commitment to this study,” said Laminate CEO Tammy Gilon.  “The results will be an important addition to the mounting evidence supporting the benefits of VasQ to promote the usability of both forearm and upper arm fistulas.”

Society of Interventional Radiology’s First-Ever Position Statement on the Role of Percutaneous Ablation in the Treatment of Renal Cell Carcinoma

For some patients, kidney cancer can be effectively treated without surgery, according to the Society of Interventional Radiology’s first-ever position statement on the role of percutaneous ablation in the treatment of renal cell carcinoma.

The position statement was published with an accompanying quality improvement document, which establishes performance thresholds for patient safety for IR groups who wish to develop a renal ablation practice.

The position statement and quality improvement document, published in the February issue of SIR’s flagship Journal of Vascular and Interventional Radiology (JVIR), were written by a multidisciplinary group of experts, including interventional radiologists and urologists.

The authors recommend thermal percutaneous ablation (PA) for kidney cancer patients with small renal tumors calling it “a safe and effective treatment with less complications than nephrectomy [surgery] and acceptable long-term oncological and survival outcomes.”  Unlike current existing guidelines, the position statement offers recommendations on the consideration of treatment over active surveillance and discusses the incorporation of ablation for appropriate patients with T1b disease.

“Interventional radiologists are critical members of the multidisciplinary team caring for patients with kidney cancer. They have an important role, not only in the diagnosis of cancer but in its definitive treatment,” said SIR President Laura Findeiss, MD, FSIR. “An image-guided biopsy by an IR can confirm a diagnosis of cancer and the interventional radiologist can be a game-changer as a partner physician on the cancer care team, expanding access to the complete range of therapeutic options, tailored to the individual patient.”

The position statement’s authors deemed radiofrequency ablation, cryoablation, and microwave ablation “appropriate modalities” noting that the “method of ablation should be left to the discretion of the operating physician.”

According to the statement, PA may have a potential beneficial role to play in the treatment of high-risk patients with more advanced disease who are not candidates for surgery, but further research is necessary. Read the full position statement and quality improvement guidelines on jvir.org.

Renal cell carcinoma (RCC) is the most common type of kidney cancer and an estimated 73,820 new cases of kidney cancer will be diagnosed in the United States in 2019, resulting in 14,770 new deaths.

Jeff Mack Appointed New CFO at Potrero Medical

Jeff Mack is joining the Potrero Medical executive leadership team as its Chief Financial Officer (CFO) and will report to CEO Joe Urban.

Jeff Mack brings more than 30 years of finance and capital markets experience to Potrero Medical. He also has in-depth knowledge of scaling medical technology startups into significant success stories.

“I couldn’t be more thrilled to welcome a well-respected healthcare leader like Jeff. He will undoubtedly make an immediate impact as we prepare for a monumental year in our company’s history,” said Joe Urban, CEO of Potrero Medical. “I am particularly impressed with Jeff’s track record of success at multiple MedTech companies. I know that he will be coming to Potrero with the experience, momentum, and powerful strategies to help Potrero achieve great success.”

Jeff Mack comes to Potrero with a long history of helping companies raise both private and public financing. Most recently, he led finance at Outset Medical, an innovative hemodialysis company. While at Outset, Jeff played a key role in raising over $250M through the company’s private financing transactions. Along with leading the company financially he also oversaw the human resources and information technology groups where improved systems and processes were deployed to support Outset’s rapid growth.

“I am particularly impressed with Potrero’s vision around protecting the kidney, and the passion and strong alignment the Potrero team demonstrates every day,” shared Mack. “Coming from the hemodialysis industry, I appreciate the tremendous importance of kidney health.”

Potrero Medical has globally launched its Accuryn® Monitoring System to enable precision fluid management while developing predictive algorithms for critical events such as Acute Kidney Injury and Intra-Abdominal Hypertension.

“I’m committed to helping Potrero build on its recent momentum and allocate resources to achieve its greatest priorities. It will be an exciting year for the team.”

Jeff has already started his role last month, most recently attending meetings with Potrero leadership during the 2020 JP Morgan Healthcare Conference.

Brett Swansiger Hired As Chief Commercial Officer at DxTerity

Brett Swansiger has been hired to serve as Chief Commercialization Officer at DxTerity.

As Chief Commercial Officer and SVP of Managed Care, Brett Swansiger will be responsible for building DxTerity’s US market position by identifying, developing, and negotiating strategic business partnerships with life-science organizations as well as establishing government and commercial payer contracts for DxTerity testing. This includes establishing strategic alliances, companion diagnostic development programs, intellectual property (in/out) licensing, and joint ventures that fit within DxTerity’s overall corporate strategy.

Brett Swansiger brings over 20 years of commercial leadership, international business development, and managed care contracting experience within the molecular diagnostics and pharmaceutical industries. Prior to joining DxTerity, he held multiple commercial leadership positions at MDxHealth Inc., a multi-national urologic oncology company, including VP of Managed Care and Payer Strategy, SVP International Business Development & European Sales, and SVP of US Sales & Integrated Healthcare Systems.

Brett Swansiger has had significant success with establishing licensing and clinical study contracts with diagnostic and pharmaceutical market leaders as well as getting key integrated healthcare systems like Kaiser Permanente, the Veteran’s Administration, the Department of Defense, and Geisinger to adopt new molecular diagnostic testing pathways. Prior to joining MDxHealth, Brett was Vice President of Managed Care and Asia Market Access for Agendia Inc., and he held multiple commercial leadership positions at Prometheus Laboratories Inc., a Nestlé Health Science company that focuses on personalized medicine for autoimmune disorders.

“We are excited to have Brett Swansiger on board. Over the last year, DxTerity has made tremendous progress in bridging the power of precision medicine to autoimmune disease. Our type 1 interferon (IFN-1) test for systemic lupus erythematous (SLE), the most common form of lupus, has been shown to be a significant predictor of a patient’s risk of developing lupus nephritis (p=0.0008) and it is being used extensively by pharmaceutical companies in clinical trials. The IFN-1 test is now available for patient use, and Brett’s experience with obtaining reimbursement and contracting with manage care organizations will play a pivotal role in this testing being adopted by the medical community across the US,” according to Bob Terbrueggen, Founder and CEO of DxTerity Diagnostics.

Bentsi Algazi Appointed VP of Operations of Sorrel Medical

Bentsi Algazi as Vice President of Operations to meet growing interest in its award-winning wearable self-injection devices.

As VP Operations, Bentsi Algazi will oversee all of Sorrel’s supply chain, engineering, production and vendor management activities. He brings over 20 years’ managerial experience in R&D, operations, procurement and production management in both high-tech and medical device markets, with a proven history of success in implementing customized innovative management and business solutions.

“Sorrel’s proprietary wearable drug delivery platform is receiving considerable attention from leading pharmaceutical and biotech companies amid growing demand for patient-friendly and partner-focused solutions,” said Andrei Yosef, PhD, CEO for Sorrel Medical. “As Sorrel progresses from R&D to manufacturing, we continue to invest in our Operations team. We are delighted to welcome Bentsi to Sorrel, where his extensive experience in operations and supply chain management will prove integral to expediting our production capabilities.”

Bentsi Algazi joins Sorrel from Juganu Ltd., a leader in smart lighting, networking and sensing solutions for municipal and commercial markets, where he served as Chief Operations Officer. Prior to Juganu, he was Micro-Infusion R&D Site Manager at West Pharmaceutical Services, Inc., leading the team responsible for bringing the company’s SmartDose® wearable injector to commercialization. Before joining West, Bentsi served as COO at PowerPaper, a developer of micro-electric solutions for cosmetic & RFID applications.

“Sorrel Medical is emerging as a key player in the wearable injector and connected drug delivery space, bringing innovative solutions for the safe and efficient self-administration of new biologic medications,” said Bentsi Algazi. “I am excited to join Sorrel’s dynamic team with a culture of excellence committed to working with pharmaceutical partners to enhance the self-administration experience for potentially millions of patients.”

American Diabetes Association® Awards $3.25 Million for Innovative Diabetes Research

The American Diabetes Association (ADA) is awarding this year’s prestigious  Pathway to Stop Diabetes grants, totaling $3.25 million dollars, to two promising researchers. Both will receive $1.625 million dollars over a five-year grant term to support breakthroughs in basic science, clinical science, technology, care and potential cures in the field of diabetes.

  • Judith Agudo, PhD, Dana-Farber Cancer Institute in Boston, Massachusetts, receives a Pathway Accelerator Award for her research project titled “Harnessing immune privilege mechanisms from stem cells to protect beta-cells from immune attack.”
  • Maxence V. Nachury, PhD, University of California, San Francisco, receives a Pathway Visionary Award for his research project titled “Regulation of body weight homeostasis and beta-cell function by primary cilia.”

“Congratulations to our 2020 Pathway to Stop Diabetes research grant awardees, Dr. Agudo and Dr. Nachury,” said Dr. Kenneth Moritsugu, Interim Chief Science and Medicine Officer for the American Diabetes Association. “The Pathway program is groundbreaking and identifies promising researchers at the peak of their creativity. It provides them with the financial and professional support they need to be innovative and produce something great. Alongside the 32 other Pathway researchers we’ve supported since the program began in 2014, I have no doubt that the work or Dr. Agudo and Dr. Nachury will help those living with diabetes truly thrive and bring us closer than ever to finding a cure for diabetes.”

“Research is in our DNA and it is our foundation,” added Tracey D. Brown, CEO of the American Diabetes Association. “The Pathway program allows us to continue our mission through the great minds of young and talented researchers who will one day find a cure and end this diabetes epidemic!”

Learn more about Pathway to Stop Diabetes and the research of Drs. Agudo and Nachury at diabetes.org/pathway.

About Pathway to Stop Diabetes

Now in its seventh year, the Pathway program is a revolutionary grant designed to transform diabetes research by attracting brilliant scientists through financial support and professional mentorship and guidance. Since the Pathway program began, 34 scientists have been selected, putting us well on the path to our goal of bringing 100 brilliant scientists to diabetes research. Since Pathway launched, nine awardees have secured their first independent faculty positions, thirteen invention disclosures and patent applications have been filed and over 160 manuscripts have been published in peer-reviewed journals by Pathway awardees.

Pathway grants are awarded in three categories:

  1. Pathway Initiator, for postdoctoral fellows who are transitioning from training to independent research;
  2. Pathway Accelerator, for diabetes researchers early in their independent careers; and
  3. Pathway Visionary, for scientists established in another field who are interested in applying their expertise to diabetes research for the first time.

Pathway awardees are selected by the ADA’s Mentor Advisory Group—eminent scientists who review the core elements of exceptional science in selecting an awardee: rigorous thought processes, keen intellect, and capacity for innovation, creativity and productivity. The advisors also provide the Pathway awardees with mentorship, and scientific and professional guidance throughout the duration of their grant.

“In my six years on the Pathway mentor and selection committee, I have observed the extraordinary impact of the program first-hand,” said Christopher B. Newgard, PhD, chair of the Mentor Advisory Group. “The process has been highly competitive, with many years seeing more than 100 submitted applications across the three funding categories. This has meant that the quality of science funded has been exceptional, and the grants have clearly stimulated the launch and development of careers focused on diabetes research projects with exciting translational implications. The two awards for 2020 continue this tradition of excellence.”

Pathway is generously supported by more than 53 million dollars in contributions from corporate sponsors, individuals and foundations since the program began. Our 2020 Pathway awardees are supported in part by Discovery Sponsor, Eli Lilly and Company and Initiator Sponsor Merck & Co., Inc. “As long as people continue to live with diabetes, research that leads to better outcomes is needed,” said Sherry Martin, MD, Vice President of Medical Affairs, Eli Lilly and Company. “Lilly supports the Pathway Program because we are committed to finding new ways to improve the lives of people who are affected by this condition. With federal funding under increased pressure, diabetes research is at risk without important initiatives such as the Pathway Program. We applaud the American Diabetes Association for its commitment to funding this important work.”

CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

CardioFocus announced they have submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib.

This supplement follows the original, approved PMA of the HeartLight Endoscopic System. U.S. commercial launch of the HeartLight X3 System will immediately follow the approval of the PMA supplement.

The HeartLight X3 System is a next-generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System. The system performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System offers a unique RAPID mode. RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under the direct control of the physician, resulting in significantly reduced procedure times. During the pivotal confirmatory study of 60 patients, the HeartLight X3 System achieved very rapid PVI, in as few as three minutes for a single vein.

“The excitement surrounding the introduction of HeartLight X3 into the European market has been palpable,” said Burke T. Barrett, Chief Executive Officer at CardioFocus. “We have treated nearly 500 patients with the technology and the ability to deploy rapid, continuous laser energy circumferentially and outside of the pulmonary vein is compelling. The submission of this PMA supplement marks a tremendous milestone as we prepare to bring this breakthrough product to the U.S. Based on our initial interactions with FDA, we anticipate launching HeartLight X3 into the U.S. market this year.”

EVO Implantable Lens US Clinical Trial is Underway: Announces STAAR Surgical

STAAR Surgical Company today announced the first patient was implanted in the Company’s U.S. human clinical study for its EVO ICL family of lenses. The investigational study, “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens,” will be conducted at more than a dozen ophthalmology clinics across the United States.

EVO Visian ICLs are intended to treat a wide range of refractive error, including myopia (nearsightedness) which is the need for distance vision correction. Myopia is the most common ocular disorder worldwide and its incidence is increasing rapidly. An estimated 1.9 billion people globally have myopia and this number is projected to rise by 52% by the year 2050.1

STARR Surgical President & CEO Caren Mason notes: “Enrolling and implanting patients in the U.S. trial of our EVO family of implantable Collamer lenses is the next step in opening the U.S. market, the second-largest market in the world for refractive vision correction, to our latest generation of lenses.”

She added, “Surgeons outside the U.S. have implanted in excess of 750,000 of our EVO lenses in patients as the need for distance vision correction grows. We look forward to the U.S. study of our EVO lenses generating additional safety data on our implantable Collamer lenses.”

Ophthalmology clinics participating in the study include locations in the following metropolitan areas: Indianapolis, Chicago, Dallas, Washington D.C., Philadelphia, St. Louis, San Antonio, Kansas City, Cleveland, Honolulu, Omaha, Fargo and Salt Lake City.

The first patient in the U.S. clinical study of EVO implantable lenses was enrolled at Price Vision Group in Indianapolis. Francis W. Price, Jr. MD, study investigator and founder of Price Vision Group and the Cornea Research Foundation of America, stated, “My team and I very much enjoy investigating new and next-generation approaches that may help patients. I am honored to be the first member of the principal investigator’s group to enroll and implant a patient with the EVO ICL in the United States. This latest version of the Visian ICL, the EVO lens, has a central port that eliminates the need for a peripheral iridotomy (a hole in the iris or colored part of the eye) prior to implanting the lens. Slightly smaller in size to a contact lens, these remarkable ICL lenses are designed to provide vision correction and intended to remain in place as long as the patient is satisfied with his or her vision. The lenses are made of a very thin, soft, flexible and highly-biocompatible Collamer material and are removable if the patient is not happy, or develops a cataract as part of the normal aging process. Price Vision Group already has extensive experience working with the earlier versions of the Visian ICL that have been approved in the U.S. since 2005. Our practice has routinely sought out opportunities to evaluate the most promising vision correction treatments on the horizon, and we look forward to our continued participation in this current study of the EVO lenses.”

A list of participating clinics across the U.S. and additional details on the clinical trial protocol, which has a primary endpoint at six months follow-up, will be posted on ClinicalTrials.gov under “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens” in late February.

Orthofix Medical Announces Agreement to Acquire FITBONE Limb Lengthening System

Orthofix Medical Inc. today announced an asset purchase agreement with Wittenstein SE, a privately-held German-based company, to acquire assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones.

Additionally, the transaction brings other potential applications of the technology, which are in preliminary development, including the FITSPINE® system for early-onset scoliosis. Terms of the agreement include $18 million in cash closing consideration and a manufacturing supply contract with Wittenstein SE.

“Founded 40 years ago as an extremity fixation company, Orthofix Medical has a long history of cutting-edge solutions to treat patients born with limb discrepancies,” said Orthofix Medical President and Chief Executive Officer Jon Serbousek. “The addition of the FITBONE intramedullary lengthening system further rounds out our limb reconstruction offerings and is well aligned with our strategy of investing in innovative products to drive growth within our core businesses.”

The FITBONE system consists of an intramedullary lengthening nail that is surgically implanted in the bone through a minimally invasive procedure, an external control set that manages the distraction process, and the FITBONE app that supports the patient throughout the limb lengthening treatment. Over 3,500 cases in more than 15 countries have been performed with the FITBONE system.

With the addition of the FITBONE system, Orthofix Medical becomes the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction. The FITBONE system will augment Orthofix’s current deformity and limb reconstruction offerings that include the TL-HEX™ computer-assisted ring fixation system for external limb lengthening and the eight-Plate Guided Growth System™ for correcting angular growth deformities in pediatric patients. To learn more about Orthofix’s dedication to helping surgeons and limb deformity correction patients, please visit JuniOrtho.club.

“We are proud that we could bring a product such as the FITBONE intramedullary lengthening system to the market to help people in need of limb lengthening,” said Dr. Bertram Hoffmann, Chief Executive Officer of Wittenstein SE. “It has long been our goal to increase global availability. We are pleased that through Orthofix, more surgeons and their patients will have access to this innovative technology that can make a huge difference in an individual’s quality of life.”

The FITBONE intramedullary lengthening system is available in the U.S. under a U.S. Food and Drug Administration 510(k) clearance and in European Countries under a CE Mark approval. The acquisition is anticipated to close by the end of the first quarter of 2020, subject to customary closing conditions. Orthofix does not expect the transaction to be material to 2020 net sales. More information regarding this announcement will be made available during the Company’s fourth quarter and fiscal year 2019 financial results call.

Bactiguard Makes its First Acquisition by Acquiring Vigilenz

February 4, 2020

Bactiguard Holding AB (publ) (Bactiguard) has entered an agreement to acquire Vigilenz, a Malaysian manufacturer and supplier of medical devices and consumables, primarily active in wound management and infection control.

Bactiguard and Vigilenz have been partners since 2015, when an agreement to develop Bactiguard-coated orthopaedic trauma implants was signed. The implants were CE-marked in late 2018, which paved the way for Bactiguard’s global license agreement with Zimmer Biomet.

Vigilenz has a portfolio of products ranging from surgical sutures, mesh, wound wash and dressings, to orthopaedic trauma implants. One product which Bactiguard considers has significant potential is HYDROCYN aqua®, for advanced wound management of acute and chronic wounds. The product is CE-marked and has been registered by the US FDA. Vigilenz’s research and development activities focus on biomaterials for medical application, urology, cardiovascular and wound management products, with the aim of reducing device related infections. It also has a strong regional distribution network in South East Asia.

“Acquiring Vigilenz makes perfect sense. Together we will have a much stronger offer for infection control and will be able to access the market for advanced wound care, which has a global potential of over USD 5 billion”, says Christian Kinch CEO.

“The transaction will result in substantial synergies both in revenues and cost, by pooling our distribution networks, product development teams, staff functions and production facilities. I am glad that Professor Choudhury has agreed to stay in the business and become a shareholder in Bactiguard, as I see great potential in jointly developing new products and license applications for improved patient outcomes. This is a clear win-win for both companies,” Christian Kinch continues.

In 2019, Vigilenz had a preliminary, consolidated pro forma turnover of approximately MYR 18 million (approx. SEK 42 million), EBITDA of MYR 2.6 million (approx. SEK 6 million) and an EBITDA-margin of 14 percent.

As a result of the acquisition, joint revenues are expected to grow faster than on a stand-alone basis, as the product portfolios are complementary and can be offered throughout both companies’ footprint. In a three to five year perspective, Bactiguard also expects cost synergies of SEK 5-10 million.

The transaction is therefore financially compelling and significantly accretive to revenues, earnings and cash flow.

Highlights of the acquisition
The shareholders of Vigilenz, including the founder, Chief Executive and majority shareholder Professor Choudhury, have unanimously accepted Bactiguard’s offer. The total consideration consists of:

  • a cash payment of USD 4.5 million, payable at closing and;
  • subject to approval by the shareholders in Bactiguard at the AGM on 28 April 2020,  241 512 new class B-shares in Bactiguard, equivalent to a value of USD 2 million.
  • As a result of the acquisition, Bactiguard also assumes net debt of close to SEK 12 million (approximately USD 1.2 million).

The new class B-shares will be subject to a lock-up period of 12 months, during which period the shares may not be sold.

The cash portion will be financed through bank facilities provided by Skandinaviska Enskilda Banken (SEB), with a term of three years. At the same time, the term of Bactiguard’s current bank facility with SEB will be extended and have the same tenor.

Closing of the acquisition and payment of the cash portion of the purchase price shall take place 10 business days after the following condition precedents have been fulfilled:

(i) Bactiguard has received approval from SEB with firm and unconditional commitment regarding the financing of the cash portion of the purchase price; and
(ii) Vigilenz’s bank approves the change of control of Vigilenz.

It is expected that these conditions precedent will be fulfilled no later than 14 February 2020 and, hence, that closing will occur before the end of February 2020.

The Bactiguard Board of Directors has approved the transaction and shareholders including Christian Kinch, Thomas von Koch, Jan Ståhlberg, The Fourth Swedish National Pension Fund (AP4) and Nordea Investment Funds, together representing approximately 66 percent of the capital and 84 percent of the votes in Bactiguard have declared that they will support the issuance of new class B-shares at the AGM.

 

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