Showing all posts written by Michael Burns

Michael Burns
Michael Burns
Michael Burns is an associate in the firm's Orange County office. Dr. Burns' practice focuses on patent prosecution for mechanical, medical device, and life science clients.

Prior to joining the firm, Dr. Burns did post-doctoral research on cardiovascular systems. At the University of Chicago, Dr. Burns was awarded the Ruth L. Kirschstein National Research Service Award to study how oxygen affects blood vessel growth in the lung. At the Ohio State University, Dr. Burns designed and built a flow system for studying how best to restore blood flow after someone has suffered a heart attack.

Dr. Burns worked as a summer associate at the firm in 2013 and joined the firm in 2014.
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Google Buys Fitbit for $2.1B

Wearable fitness products company Fitbit Inc. announced Friday it entered a definitive agreement to be acquired by Alphabet Inc.-owned Google for $7.35 per share in cash, valuing the company at approximately $2.1 billion. James Park, co-founder and CEO of Fitbit, said of the deal: “Google is an ideal partner to advance our mission. With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone.” The deal is expected to close in 2020.

Founded in 2007, Fitbit launched its step-counting Fitbit Tracker at the end of 2009. The wearables market has grown rapidly in the past decade. According to IDS, Apple leads the wearables market with 16.2 million devices sold in the 4Q18, followed by Xiaomi, Huawei, Fitbit, and Samsung. Google’s presence in wearables includes WearOS.

“This move should put the eHealth market on alert—Google just acquired 25-30 million active users who care about monitoring their health. This is exactly the demographic that eHealth is designed to reach. And I would say that ‘preventative health’ within eHealth just got more competitive.”  – Michael Luther, Co-Founder and CEO of MX3 Diagnostics

This year Fitbit sought to diversify its income stream by working with health care companies and offering subscription-based services. Some analysts see the Fitbit acquisition as a data play on Google’s part. Tom Taulli of InvestorPlace notes: “Google is a global leader in AI and this technology will likely prove extremely useful in transforming the healthcare industry.” Omri Shor, CEO of Medisafe notes: “Quality AI is predicated on an abundance of validated data, the tools to analyze that data in a meaningful way, and the ability to drive action. Google and FitBit together certainly have the potential to develop groundbreaking AI.” D.A. Davidson’s Tom Forte agrees and said in a note to clients “We see Google as a natural acquirer for the company that would leverage Fitbit’s: 1) data, 2) hardware and 3) brand into a larger ecosystem that would allow Google to further penetrate the healthcare sector and the smartwatch category.” 

Cryoablation Competition Heats Up

Atrial fibrillation (AF), a common heart rhythm disorder, is often treated with cardiac ablation. Cardiac ablation uses RF (heating) or cryothermal (cooling) energy to scar the areas of the heart muscle that are responsible for the abnormal heart rhythm. Abbott Laboratories, Boston Scientific, and Biosense Webster (a subsidiary of Johnson & Johnson), each offer RF ablation catheters. According to one analyst, however, Medtronic is the first company to launch a cryoablation device and currently has reign over the cryoablation market. Recent developments suggest competition in cryoablation is now ramping up.

“The cryoablation market is set for disruption as Adagio Medical, Boston Scientific and a number of other smaller companies enter the space to challenge the market dominance of Medtronic’s devices.” -Sheryl Tang, senior analyst for medical devices at GlobalData.

GlobalData estimates cryoablation catheters make up approximately 27% of the global electrophysiology ablation catheters market, with the cryoablation catheter market growing at a Compound Annual Growth Rate (CAGR) of 5%. GlobalData expects small companies with successful devices in the cryoablation space to be prime acquisition targets for large companies looking to obtain a place in the cryoablation market and to secure a stronger position in the wider electrophysiology ablation market.

Laguna Hills, California-based Adagio Medical, Inc., appears to be one such small company with a cryoablation device. The company recently announced that it successfully treated its first patients with its One Shot+™ catheter. Adagio Medical describes its cryoablation platform as using continuous and uninterrupted flow of the cryogen through the catheter, allowing ultra-low temperature cryoablation catheters with diameters smaller than  2 millimeters.

In July of this year, Boston Scientific announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held company developing a single-shot cryoablation platform for the treatment of AF. According to a recent article, the Cryterion cryoablation system uses a balloon catheter, mapping catheter, and steerable sheath. The Cryterion cryoablation system is not available for sale. However, a clinical study of the Cryterion cryoablation system is reportedly being conducted in Europe, with a CE Mark submission expected in early 2019. Boston Scientific plans to submit an investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA), with patient enrollment expected to begin in 2019.

It remains to be seen whether Biosense Webster or Abbott Laboratories has interest in acquiring a company in the cryoablation space. If either company decides to do so, Adagio Medical may be a target for acquisition.

Boston Scientific Buys Venous-Stent Maker VENITI

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration in June 2018 for the VICI stent system for treating obstructive venous disease. The VICI stent system received CE Mark approval in 2013.

According to the press release, venous obstructive disease affects more than 1.1 million people in the United States and Western Europe annually. Jeff Mirviss, Senior Vice President and President of Peripheral Interventions at Boston Scientific, commented:

Along with our leading AngioJet thrombectomy platform and venous product pipeline, we look forward to meeting the needs of physicians treating both chronic and acute venous disease.

According to the Worcester Business Journal, Boston Scientific announced over $1.5 billion in acquisitions this year alone. Other notable Boston Scientific acquisitions in 2018 include Millipede ($540m), NxThera ($306m), nVision Medical Corporation ($275m), Claret Medical ($270m), and Cryterion Medical ($202m).

Boston Scientific expects the acquisition of VENITI to be immaterial to adjusted earnings per share (EPS) in 2018 and 2019, and accretive thereafter. Nonetheless, shares of Boston Scientific opened trading the day of the announcement up more than 3 percent.

DePuy Synthes Acquires Medical Enterprises Distribution LLC’s Orthopedic Assets

DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery.  The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™.  The financial terms of the acquisition are not being disclosed.  The transaction is expected to close in the second quarter of 2018.

According to Medical  Enterprises, the ME1000™ delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning in total hip arthroplasty (THA).  DePuy Synthes said that the company plans to develop and broaden the surgical impactor technology for a range of orthopaedic surgery procedures.

“The acquisition of assets of Medical Enterprises Distribution is a key example of going beyond the implant to provide complete solutions to achieve better outcomes.” – Ciro Roemer, Company Group Chairman of DePuy Synthes

The hip replacement global market was $6.5 billion in 2015 and is predicted to reach $9.1 billion by 2025.  The global market for all joint replacements is expected to reach $30 billion by 2025.  Other companies in the joint replacement markets include Zimmer Biomet, Smith & Nephew, and Stryker.

In the recent press release, DePuy Synthes also announced an exclusive marketing agreement with JointPoint Inc. to co-market a hip navigation system for  analysis of implant selection during THA.  Earlier this year, DePuy Synthes announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery for total and partial knee replacement.  In discussing the Orthotaxy acquisition, Ciro Roemer, Company Group Chairman of DePuy Synthes, said “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care.”  Other companies in the joint replacement market are likely seeking to create comprehensive orthopedic platforms as well.

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Wayne, Pennsylvania-based Teleflex Inc.  announced it will purchase privately-held NeoTract Inc. for approximately $1.1 billion. According to the press release, Teleflex will pay NeoTract $725 million when the deal closes and an additional $375 million upon NeoTract hitting certain sales goals through 2020. The companies said they expect the deal to close within the next 30 days.

According to its website, Teleflex is a global provider of medical technologies in surgical, anesthesia, cardiac care, urology, and respiratory care fields.  NeoTract describes itself as a company dedicated to developing minimally-invasive and clinically-effective devices that address unmet needs in the field of urology. NeoTract’s device, the UroLift® System, is said to treat benign prostrate hyperplasia (BPH) by using small implants to hold the enlarged prostate tissue out of the way of the urethra.

Teleflex’s CEO Benson Smith characterized NeoTract as “a truly unique company with a differentiated technology that targets a greater than $30 billion addressable market.” Smith also stated that a second-generation UroLift® System is expected to launch in the second half of 2018. NeoTract’s revenue is expected to be between $115 million to $120 million this year, compared to about $51 million in 2016, and is expected to increase at least 40 percent in 2018, the companies said in a joint statement.

Reuters notes that the deal is Teleflex’s 23rd since 2008 and follows its $1 billion acquisition of Vascular Solutions in December. Teleflex expects the NeoTract deal to slightly diluteTeleflex’s adjusted earnings this year, be neutral to profits next year, and be accretive starting in 2019.

Philips Buys RespirTech for Undisclosed Amount

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which help fight respiratory disease. According to a news release, the terms of the deal were not disclosed.

RespirTech’s website states that the inCourage vest uses high-frequency chest compression to help loosen and move mucus through the lungs. According to RespirTech’s website, the inCourage technology was developed by Pediatric Pulmonologist Warren Warwick, M.D., and Leland Hansen, MPH, in the early 1990’s to provide more effective secretion clearance for University of Minnesota cystic fibrosis patients.

According to Philips’ website, the conglomerate has primary divisions in the areas of healthcare, lighting, and home electronics. Philips’ 2016 annual report states that sales in its HealthTech portfolio increased 4% and topped $19 billion. In contrast, news sources state that RespirTech was founded in 2004 and reportedly had nearly $37 million in revenue in 2015.

Regarding the acquisition, John Frank, Philips’ business leader for sleep and respiratory care, said in a news release:

With this transaction, we will broaden our portfolio with a proven therapy to enable patients with chronic respiratory disorders manage their condition and receive the care they need in the home.

According to Philips’ CEO, Franz van Houten, Philips has transformed itself over the last five years into a differentiated global health tech leader. Mr. van Houten stated that the markets Philips’ serve have attractive growth and attractive profitability. According to news sources, GE Healthcare, Siemens Healthineers, and Toshiba Medical Systems are other conglomerate divisions competing with Philips in the healthcare space.

As one analyst notes, the Twin Cities have produced a number of competing companies that make vests for treating lung conditions, including New Prauge-based ElectroMed Inc., and St. Paul-based Hill-Rom.

EU Finalizes Medical Device Regulations

EU Finalizes Medical Device Regulations

The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR).  According to JDSupra, the Council of the European Union will vote on March 7, 2017 whether to adopt the MDR and the IVDR.  That vote will be quickly followed on March 20, 2017 by a vote by the European Parliament.  If adopted, the MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017.  The MDR would be applicable by 2020 and the IVDR by 2022.

The final texts retain much of the same information of the current Directives released in May 2016According to Regulatory Affairs Professionals Society (RAPS), an EU official stated that:

The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016…  The difference between these ‘old’ documents and the ‘new’ documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.

The regulations generally strengthen pre-market requirements and post-market surveillance, including establishment of a unique identification system.  For example, some experts note that under the current IVD Directive, a manufacturer is able to self-certify about 80% of all IVDs on the EU market.  However, when the IVDR becomes applicable five years after its publication, this ratio will flip so that approximately 80% of all IVDs on the EU market will require approval from a notified body.

JDSupra also reports that the two Regulations include transitional provisions that allow CE mark certificates issued in accordance with the current Directives to remain valid until the end of the period indicated on the certificates.  According to the Emergo Group consulting company, CE mark certificates issued prior to final implementation of the new regulations in late 2019 or early 2020 will have a maximum validity of five years.  CE mark certifications issued before implementation of the new regulations will expire automatically four years after the new regulations come into force.

As the Regulations will impact nearly every device manufacturer that sells products in the EU, device manufacturers are well-advised to consider their existing products and procedures in view of the Regulations to avoid future problems when marketing their devices.

 

 

 

 

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

Medical Device Investor Forum – Oct. 27-28 in Irvine, CA

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016, in Irvine, California.  The speakers for this year’s MDIF include Mike Mussallem, Chairman and CEO of Edwards Lifesciences; Tom Burns, President and CEO of GlaukosJim Mazzo, Global President of Ophthalmology, Carl Zeiss Meditec; Brett Wall, Sr. VP and President of Brain Therapies, Medtronic; and Geoff Martha, EVP and Group President of Restorative Therapies Group, Medtronic.  A number of companies will also present new strategies for maximizing funding options.  The forum is expected to attract over 600 attendees.

According to its website, OCTANe fosters a successful ecosystem that accelerates the flow of ideas, talent, and capital by creating an infrastructure where entrepreneurs, academia, company executives, and business advisors build and grow sustainable organizations.  OCTANe’s members include Orange County technology executive leaders, entrepreneurs, investors, venture capitalists, academicians, and strategic advisors, all working together to fuel innovation in the OC.  OCTANe has helped more than 800 companies via the LaunchPad™ Small Business Development Center (SBDC) accelerator.  LaunchPad™-certified companies are reported to have received more than $1.7 billion in investment and equity exits.

The agenda for this year’s MDIF includes a keynote address by Dr. Wallace Walrod, Chief Economic Adviser of the Orange County Business Council, and Herm Cukier, Sr. VP of Eye Care, Allergan, on Allergan’s economic impact on Orange County.  A panel moderated by Clay Wilemon, CEO and Chief Strategy Officer of DevicePharm, will discuss using big data to improve patient outcomes and reimbursement.  Sabing Lee, a Partner at Knobbe Martens, will host a panel discussing medical device security.  And, U.S. Congresswoman Mimi Walters will address the importance of innovation in Orange County, and healthcare legislative and policy expert Jeff Kimbell will provide his views on the upcoming elections from a Washington D.C. perspective.

OCTANe annually welcomes more than 7,000 people to its programs and events, and more than 2,000 business leaders throughout the Orange County region are OCTANe members. Bill Carpou, CEO of OCTANe, describes the MDIF as “the most important event of the year when it comes to medical technology and Orange County.”

Zimmer Biomet Buys LDR Holding for $1 Billion

Warsaw, Indiana-based Zimmer Biomet Holdings Inc.  recently announced it will purchase LDR Holding Corp. for approximately $1.0 billion.  PR Newswire notes that Zimmer Biomet will commence a tender offer to acquire all outstanding shares of LDR at a price of $37 per share, a 64% premium over LDR’s trading price prior to the announcement (however, as Bloomberg notes, LDR’s shares lost 49% in the last 12 months).  The companies expect to complete the transaction in the third quarter of 2016.

According to it’s website, Zimmer Biomet designs, manufactures, and markets orthopedic reconstructive products for musculoskeletal healthcare, including  knee, hip, surgical, spine, and dental franchises.  LDR describes itself as a global medical device company focused on the development of innovative technology for spinal procedures.

Zimmer Biomet’s 2015 annual report notes that the spine segment is one of the company’s smallest franchises, accounting for only about 7% of total sales.  Analysts predict Zimmer Biomet’s acquisition of LDR will increase the company’s share of the global spine market from about 5 to 7%, moving Zimmer Biomet from No. 6 to No. 5 in that sector.  Regarding the acquisition, David Dvorak, Zimmer Biomet President and CEO, said:

This highly strategic and complementary transaction will enhance Zimmer Biomet’s innovation leadership in musculoskeletal healthcare by adding a premier spine platform to our portfolio of solutions.

We are confident that the combination of Zimmer Biomet’s Spine division and LDR will create a Spine company with the scale, talent and technology portfolio to become a leader in the $10 billion global Spine market.

The LDR acquisition comes merely one year after Zimmer completed its combination with Biomet in a cash and equity transaction valued at over $14 billion.  At least some analysts believe that Zimmer Biomet’s purchase of LDR signals that the recently-combined company has wrapped up the integration and moved on to growing the company via M&A using its sizeable cash reserves.

Box DICOM Viewer Cleared as Class II Medical Device

California-based Box Inc. announced recently that the FDA has cleared the company’s DICOM Viewer as a Class II Medical device. DICOM, which stands for Digital Imaging and Communications in Medicine, is the standard for the communication and management of medical imaging information and related data. The standard was developed in the early 1980s and facilitates communication of digital image information from imaging modalities such as CT scans, MRIs, ultrasounds, and x-rays. According to Box’s website, the Box DICOM Viewer allows users to store, view, and share DICOM images from the web or any mobile device.

Box made the FDA clearance announcement during the Healthcare Information and Management Systems Society (HIMSS) Conference that was held in Las Vegas, Nevada. This year’s HIMMS Conference attracted over 45,000 persons from 75 countries, with over 1200 companies attending as well. This large attendance reflects a high level of interest in healthcare-related information technology (IT), which is not surprising given a recent prediction that FDA-regulated digital health solutions are expected to save the U.S. healthcare system more than $100 billion over the next four years. Analysts also predict that FDA approvals of digital health solutions will triple to 100 by the end of 2018, up from 33 in 2015.

One way that the FDA “clears” a medical device is when the device is found to be “substantially equivalent” to a device that has already been “approved” by the FDA. Here, Box’s DICOM Viewer was predicated on an FDA-approved picture archiving and communication system (PACS) that was developed by Clariso, Inc., which now operates as a subsidiary of Box.

TransEnterix Acquires ALF-X for $99.8 Million

Research Triangle Park, North Carolina-based TransEnterix, Inc. announced today that it has acquired the surgical robotics division of SOFAR S.p.A., an Italian health care company. According to the announcement, the deal is a cash and stock transaction with a total consideration of $99.8 million.

According to its website, SOFAR manufactures medicines, nutraceuticals, and medical devices, specializing in therapeutic areas such as gastroenterology, gynecology, urology, and dermatology. SOFAR’s website notes that the company was founded in 1968 and currently has approximately 350 employees. According to its website, SOFAR invested heavily over the last twelve years in developing TELELAP ALF-X, an advanced robotic system for minimally invasive laparoscopic surgery., and that the TELELAP ALF-X system was granted CE certification in 2012.

According to TELELAP ALF-X promotional materials, the system has a surgical cockpit that allows open view of the operation theater.  Tool control is realized through laparoscopic-like input devices. The system also includes 3-D stereo vision with polarized glasses and incorporates a full eye-tracking system.  SOFAR recently announced that the TELELAP ALF-X system is being used for minimally-invasive gynecological procedures.

According to its website, TransEnterix is focused on the development and commercialization of its SugiBot System, a robotically-enhanced laparoscopic surgical platform that allows the surgeon to be patient-side within the sterile field. According to  TransEnterix President and CEO, Todd Pope:

We believe this combination accelerates our commercialization timeline and revenue ramp as we can immediately begin selling the ALF-X in many markets globally.

In its press release, TransEnterix emphasized the advantages of combining the SurgiBot and ALF-X systems.  According to TransEnterix, this acquisition will allow TransEnterix to accelerate the migration of traditional laparoscopy to robotically-assisted laparoscopy by eliminating cost barriers to adoption.  TransEnterix stated that a transition to robotically-assisted laparoscopy could potentially be quite positive for TransEnterix given that laparoscopic procedures represent over 10 times the number of existing robotic surgery procedures.

Medtronic to Acquire Transcatheter Mitral Valve Startup

Medtronic recently agreed to pay up to $458 million for California-based Twelve, Inc., a privately-held developer of transcatheter mitral valve replacement devices.  The terms of the deal include $408 million at closing and $50 million on achievement of CE Marking. The deal is expected to close in October 2015.

Medtronic now joins fellow multi-billion dollar med-tech giants, Edwards Lifesciences and Abbott Laboratories, in the race to stake a claim in the transcatheter mitral valve device space.  In July, Edwards paid $400 million for CardiAQ Valve Technologies, a transaction that just recently closed, and Abbott acquired Tendyne Holdings, Inc. for $250 million.

Medtronic presently offers two transcatheter heart valves: “CoreValve Evolut R” for aortic valve replacement and “Melody” for pulmonary valve replacement. Sean Salmon, SVP and President of Medtronic’s Coronary & Structural Heart division stated:

Upon close, this acquisition will strategically augment our existing capabilities in the transcatheter mitral space, which represents an important growth opportunity for Medtronic.

Medtronic’s Coronary & Structural Heart division accounted for nearly $3 billion of the company’s $17 billion FY2014 revenue. The planned acquisition of Twelve suggests that Medtronic seeks to aggressively increase its market-share.

Abbott Expands Presence in Heart Valve Repair

Illinois-based Abbott Laboratories recently announced two transactions intended to increase Abbott’s presence in mitral valve replacement therapy and bolster its structural heart portfolio.  First, Abbott will acquire Minnesota-based Tendyne Holdings, Inc. for $250 million.  Second, Abbott provided capital and secured an option to purchase California-based Cephea Valve Technologies – financial terms were not disclosed.

According to its website, Tendyne is a private medical device company focused on minimally-invasive mitral valve replacement therapies and does not yet have a commercially available product. However, in April, the Minneapolis Heart Institute Foundation reported the first successful U.S. implant of a Tendyne heart valve.  Tendyne’s Bioprosthetic Mitral Valve System has approval from the U.S. Food and Drug Administration for a feasibility clinical trial to provide data about the device’s safety and effectiveness.  Enrollment in the trial has already begun.  Tendyne also plans to begin a clinical trial in Europe to support a CE Mark.

Cephea Valve Technologies is a private company focused on developing a transcatheter mitral valve replacement therapy. Cephea’s valves are at an early stage of development and have not yet begun clinical trials.

Before Abbott announced these transactions, Abbott’s only structural heart product was MitraClip, an endovascularly-delivered device that has been used to treat more than 25,000 people. The Tendyne and Cephea valve technologies, like MitraClip, are designed to be implanted in a beating heart without the need for open heart surgery. John M. Capek, Ph.D., Executive Vice President of Ventures for Abbott stated:

The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them.

The mitral valve is positioned between the left upper and lower chambers in the heart.  Some analysts believe that transcatheter mitral valves could address an even larger market than transcatheter aortic heart valves.  There may be agreement among industry players: earlier this month, Edwards Lifesciences Corp., which has strong sales growth for its aortic valves, reached a $400 million deal to acquire CardiAQ Valve Technologies, another company focused on developing transcatheter mitral-valve replacement therapies.

 

Cardinal Health to Acquire The Harvard Drug Group for $1.1 Billion

Ohio-based Cardinal Health (CAH)  has agreed to buy Michigan-headquartered The Harvard Drug Group (THDG) for $1.12 billion. According to press releases, THDG, which is currently owned by Court Square Capital Partners, is a distributor of generic pharmaceuticals and over-the-counter medications to retail and institutional customers. The deal is expected to close in the beginning of fiscal year 2016 and will be paid for using existing cash and new debt.

Cardinal Health predicts the acquisition will enhance Cardinal’s generic pharmaceutical distribution and enable specialized packaging offerings to meet the needs of hospital systems and other institutions. Cardinal Health chairman and chief executive officer George Barrett said:

” The Harvard Drug Group aligns perfectly with our commitment to provide the most comprehensive line of pharmaceutical products for the broadest range of customers… This acquisition enhances our ability to support retail and institutional customers and further utilizes Red Oak, our joint venture with CVS Health to source generics…”

According to the press release, the deal includes THDG’s 450 employees and two distribution facilities.  THDG had revenues of approximately $450 million in 2014. Cardinal Health projects the acquisition will add 15 cents to Cardinal’s earnings per share in fiscal year 2016.

The deal is not the first announced by Cardinal Health this year. In March, Cardinal announced it would acquire Johnson & Johnson‘s Cordis business  for $1.94 billion cash.

 

Expedited Access Program Begins For Medical Devices

Expedited Access Program Begins For Medical Devices

On April 15th, the U.S. Food and Drug Administration (FDA) began its Expedited Access Program (EAP), which is designed to get certain medical devices to market sooner. Under the EAP program, device sponsors collaborate early with Center for Devices and Radiological Health (CDRH) staff to put together a Data Development Plan with the agency.

Jeffrey Shuren, director of the CDRH, states that the EAP is a way “to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.” Shuren goes on to say that “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”

To participate in EAP, a device sponsor must submit to the FDA a request for EAP designation. Factors the FDA considers when making benefit-risk determinations for devices subject to premarket approval applications (PMA) are discussed here.

To receive EAP designation, a device must meet three criteria:

(1) the device is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition;

(2) the device meets at least one of the following criteria: (i) no appropriate alternative treatment or means of diagnosis exists, (ii) the device represents a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology, (iii) the device offers significant, clinically meaningful advantages over existing legally marketed alternatives, or (iv) the availability of the device is in the best interest of patients; and

(3) the sponsor submits an acceptable draft Data Development Plan.

Cardio3 BioSciences Acquires CorQuest Medical

Cardio3 BioSciences recently announced that it has acquired CorQuest Medical Inc. Financial terms were not disclosed. CorQuest Medical is a U.S.-based company that develops new devices and technologies for cardiac surgery. CorQuest Medical’s co-founder, Dr. Didier De Cannière is the inventor on a number of U.S. Patent Applications directed to establishing a minimally-invasive access route to a patient’s left atrium (for example, patent/applications 1, 2, 3, etc.). Cardio3 BioSciences is a Belgian biopharmaceutical company focused on developing the “Cardiopoiesis platform,” which, according to the company’s website, drives differentiation of multipotent stem cells into new cardiac progenitor cells.

Dr. Christian Homsy, CEO of Cardio3 Biosciences, comments:

 As part of our business strategy of building further on our cardiovascular diseases expertise, we have been actively seeking to acquire technologies that complement our existing medical devices for treating severe heart conditions. . . . The development of this technology will enable Cardio3 BioSciences to build on its leadership position in innovative therapies and devices for cardiovascular diseases.

According to Cardio3 BioSciences’ press release, the CorQuest technology platform is fully complementary with Cardio3 BioSciences’ C-Cathez® and C-Cure® programs. Cardio3 BioSciences intends to progress the device through clinical and regulatory approval processes, with the aim of obtaining CE mark approval by the end of 2016.