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25 Most Attractive Medtech Companies on the M&A Radar

Which companies remain available for potential M&A and which have already been snatched up? We’ve updated this list to reflect recent transactions and business developments.

  • Editor's Note: This slideshow, originally published in July 2018, was updated Feb. 28, 2019 to reflect new business developments involving the 25 companies that were called out last year as being attractive targets for M&A.

    The medical device and diagnostic industry saw a significant number of mergers and acquisitions in 2018, as MD+DI reported throughout the year. But what characteristics are larger companies looking for in potential acquisition targets? Needham & Co.'s Mike Matson shared some insights on the topic in a report he issued on June 29, 2018.

    "We think the primary things are high growth and large market opportunities," Matson said. "Secondarily, we think that they also prefer companies with high gross margins, differentiated products, and barriers to entry (patents, regulatory approvals, etc)."

    Matson called attention to 25 publicly traded small- and mid-cap companies that are likely to stand out based on the aforementioned attributes. Looking at the analyst's list by sector, five of the companies have cardiovascular-related offerings, four are in the increasingly competitive diabetes device space, four are orthopedic companies, and three are developing neuromodulation technologies.

    Read on to see which companies made the list (in alphabetical order), with additional insights from recent MD+DI coverage of each.

  • Abiomed

    We weren't surprised to see Abiomed on Matson's list of potential M&A targets. The company, which acquired the Impella heart pump technology back in 2005, made MD+DI's list of Company of the Year finalists in 2017.

    In 2018 FDA approved the company's Impella CP heart pump with SmartAssist, which uses an optical sensor. 

    The Impella CP heart pump had already earned FDA approval for treating patients in cardiogenic shock as well as patients undergoing high-risk percutaneous coronary intervention. The addition of the SmartAssist and optical sensor technology is intended to improve understanding of real-time, exact positioning for the heart pump and allows for repositioning without the need for imaging equipment, the company noted.

    During Abiomed's fiscal third-quarter earnings call on Jan. 31, 2019, CFO Todd Trapp provided some interesting commentary on what makes Abiomed standout.

    "Our razor-razorblade business model enables us to recover hearts and save people's lives as we deliver top tier revenue growth, greater than 80% gross margins, and an operating margin now approaching 30%," Trapp said, according to Seeking Alpha transcripts.

    "What makes Abiomed really unique is that we've been able to deliver consistent top tier financial results while at the same time making significant strategic investments in the business," Trapp said. "We're investing in new products and enhancements like SmartAssist, Impella Connect, Impella 5.5 and Impella ECP. We're focused on clinical research and potential new indications like STEMI. We've expanded our manufacturing capacity in both Danvers and Aachen to support future demand. And we also continued to add to our industry-leading commercial team and provide education and 24x7 hospitals support, all with the focus on improving patient outcomes. It is a great time to be at Abiomed, and we are very proud of what we're able to accomplish for our patients."

    That said, the company did hit a bump in the road last year when a report published through FDA's medical product safety network (MedSun) database described two issues involving Abiomed's Impella heart pumps. However, the company told MD+DI in October that the information in the MedSun report was inaccurate. For more information on that report, check out this story: Abiomed Responds to MedSun Report on Two Impella Pumps

  • AtriCure

    AtriCure, a key player in the atrial fibrillation space, certainly has some opportunity for growth. In June 2018, Matson noted in a report on the company that both the Heart Rhythm Society and the Society of Thoracic Surgeons issued recommendations in 2017 on concomitant ablation and the analyst said that should serve as a long-term tailwind to AtriCure's open-heart ablation business, which represents almost half of the company's sales.

    "And we believe increasing penetration should also continue to drive growth even if open heart procedures decline somewhat," Matson said. 

    The analyst also pointed to new product launches, such as the company's AtriClip Pro-V and Flex-V, launched in the third quarter of 2017 and the first quarter of 2018, respectively.

    This company is not without its challenges though. In March 2018, the company disclosed that it received a civil investigative demand from the Department of Justice over potential off-label marketing of the company's Deep hybrid procedure products, which account for about 10% of AtriCure's total sales. Matson said in a research note that these types of investigations typically take a year or more to be resolved, settlements generally require "manageable fines," and that "share prices decline sharply on the news but usually recover quickly."

    AtriCure's Deep procedure is not FDA approved to treat atrial fibrillation, but the devices that are used in the procedure have FDA clearances for tissue ablation and the company is currently running a trial to support approval for an atrial fibrillation indication.

    It should also be noted that this isn't AtriCure's first DoJ investigation. The agency previously investigated AtriCure for off-label marketing, physician kickbacks, and reimbursement fraud. The company ended up paying $3.8 million to settle the allegations and signed a five-year corporate integrity agreement that ended in early 2015.

  • AxoGen

    AxoGen develops nerve grafts and other surgical solutions for peripheral nerve injuries. The company's core surgical products include the Avance nerve graft (pictured), an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site; the AxoGuard nerve connector, a porcine submucosa extracellular matrix (ECM) coaptation aid for tensionless repair of severed nerves; the AxoGuard nerve protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; and the Avive soft tissue membrane, a minimally processed human umbilical cord membrane that may be used as a resorbable soft tissue covering to separate tissue layers and modulate inflammation in the surgical bed.

    AxoGen has been working to strengthen its balance sheet. In May 2018 the company reported that it had repaid a $25 million debt, which followed a $132.5 million equity raise.

    In October 2018, the Avance nerve graft received a regenerative medicine advanced therapy designation from FDA acknowledging that Avance is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition.

    In November 2018, AxoGen updated its total addressable market to be $2.7 billion. CEO Karen Zaderej said the increase is primarily based on revised assumptions for net procedure revenue values and increased prevalence of connector assisted repair in trauma cases. Zaderej also noted that AxoGen is beginning market development and clinical initiatives to further study the surgical treatment of chronic neuropathic pain, an application that could add more than $1 billion to the company's total addressable market.

    AxoGen Inc.
  • Cardiovascular Systems Inc.

    Cardiovascular Systems develops interventional treatment systems for patients with peripheral and coronary artery disease, both of which have significant market opportunities. The company's Diamondback 360 and Stealth 360 peripheral orbital atherectomy systems use a diamond-coated crown, attached to an orbiting shaft, which is designed to sand away plaque while preserving healthy vessel tissue. 

    After the company's most recent earnings call on Jan. 30, 2019, Matson reported that international expansion and new product launches will be key growth drivers for Cardiovascular Systems Inc. in the second quarter.

    This is another company on the list, however, that is no stranger to controversy. In 2017 a California jury awarded $25.1 million to a former sales manager who claimed the company gave kickbacks to doctors, promoted off-label products, and retaliated against him for reporting the information to management.

    Cardiovascular Systems also went through a 25-month investigation by the Department of Justice over physician kickbacks, which resulted in an $8 million fine and corporate integrity agreement. That investigation was settled in June 2016.

  • Conformis

    Billerica, MA-based Conformis' customized joint replacement system represented a shift in knee and hip replacement surgery because of the way it individualizes the entire process, as one orthopedic surgeon described to MD+DI back in 2016.  That same surgeon, Greg Martin, MD, of Boynton Beach, Florida, was a joint investigator on a study that was recently published in The Journal of Knee Surgery showing that patients treated with the iTotal CR knee replacement systems achieved better tibial fit and tibial rotational alignment compared to patients treated with three different off-the-shelf total knee arthroscopy products.

    “One of the compromises and decisions we surgeons often need to make intraoperatively is the best method to achieve an optimal “fit” for the patient while maintaining proper rotational alignment,” Martin, said. “The real benefit that I’ve found using Conformis implants is that this compromise is completely obviated. The implants fit precisely as designed with the in-built rotation, and enough relief to allow me to fine tune my rotation based on the specific patient’s anatomy. This is borne out in our results.”

    The year 2017 was a transitional year for the company under CEO Mark Augusti who joined Conformis in November 2016. While this transitional period earned some bearish comments from analysts like Canaccord Genuity's Kyle Rose, the longer-term opportunity afforded by the large addressable market and differentiated product position has been fairly clear from the get-go.

    In August 2018, launched its technology for hip replacement procedures. Read more about that procedure here.

    Conformis Inc.
  • Dexcom

    Few medtech sectors have been as competitive in recent years as the diabetes device space. While Dexcom faces stiff competition from Abbott and Medtronic, the company has shown that it can hold its own on the continuous glucose monitoring (CGM) front. In March 2018, FDA cleared Dexcom's G6 CGM system, which has created a considerable buzz in the marketplace, according to CEO Kevin Sayer.

    During Dexcom's first-quarter 2018 earnings call, Sayer touted the elimination of fingersticks, the simplicity of the technology's auto-applicator, and an improved on-body form factor.

    "This is the most exciting time ever to be at DexCom," Sayer said, according to SeekingAlpha transcripts of the call. "The business is performing exceptionally well, even in the face of shifting market dynamics. Not only did we see sustained strong year-over-year revenue growth, but we again demonstrated good financial leverage. As we have always said, our long-term goal is to replace fingersticks with CGM as the primary tool in glucose management across the board."

    Analysts also seemed pumped about the company's prospects. 

    "Dexcom delivered another quarter of strong sensor volumes, international sales, and new patient adds as the company continues to benefit from growing CGM awareness and what we view as a technologically superior product," Canaccord Genuity's Kyle Rose said in a note issued May 2, 2018, based on the company's first-quarter earnings. "In sum, while we continue to expect [Dexcom] will be a 'battleground stock' as investors choose sides in the continuous glucose monitoring market, we come out of the Q1 more confident in Dexcom's ability to deliver upside to current estimates/guidance, especially on the heels of a new product launch with the G6."

    In August 2018 the company announced it was acquiring TypeZero for an undisclosed sum.

    More recently, Sayer laid out DexCom's big ambitions for 2019. 

    "In light of our meaningful uptick and demand, we have set the aggressive internal goal to double our G6 production capacity by year-end," he said. "We need to expand our footprint dedicated to manufacturing within the Arizona facility, both to meet our G6 goals and in anticipation of a late 2020 launch of G7."

    In addition to scaling its manufacturing capacity, Sayer said DexCom has had to rethink how it builds its customer-facing infrastructure to better serve its rapidly growing patient base in order to build a sustainable infrastructure for the future.

    We have therefore expanded and reorganized our customer support efforts, which includes an increase of resources on our new Philippines location, as well as outsourcing other functions through third parties," he said. "This move will provide the ability to serve our customers with the same high level of quality that they have become accustomed to and grow in a much more efficient manner."

    Sayer said the expansion will result in organizational changes, including a workforce reduction at its San Diego and Arizona facilities, despite an expected overall increase in employee numbers in these locations this year.

    Dexcom Inc.
  • Endologix

    Endologix has had its fair share of hurdles over the past couple of years, but it seems like things might finally be looking up for the Irvine, CA-based company.

    In May 2018, the company promoted John Onopchenko to the role of CEO. Prior to the promotion, Onopchenko was the company's chief operating officer, a position he took in October 2017.

    "At that time, the company had recently experienced the AFX2 recall and a temporary suspension of our CE mark,"  Onopchenko told investors during the company's first-quarter 2018 earnings call, the same day his promotion was announced. "That reality drove my focus over the last six months and led me to take a critical look into our quality systems, including how we design and develop products, our production and quality management review processes, along with our supplier management practices. The team has embraced my continuous improvement mandate, and I’m proud to say that we are upping our game on all fronts."

    Endologix just took a big step forward on what has been a long and winding road to FDA approval of its Nellix endovascular aneurysm sealing (EVAS) system. The Irvine, CA-based company said the first patient was treated in its EVAS2 confirmatory clinical study of the device.

    Also in 2018, the company showed that it was making progress with its Nellix endovascular aneurysm sealing system, a highly-anticipated device that has had a rough time on the regulatory pathway. The Nellix System was developed as an alternative treatment to traditional endovascular aneurysm repair (EVAR) for an abdominal aortic aneurysm. The system is designed to seal an entire aneurysm.

    Endologix also reported positive results last year from ENCORE, a pooled retrospective analysis of six prospectively enrolled trials and registries of the company's Ovation systems. The data set includes 1,296 patients, 160 centers, and 339 investigators in the United States, Europe, and Latin America. Endologix said ENCORE standardizes outcome variables across each study and the data represents a mix of real-world registries and controlled studies.

    For the most recent MD+DI coverage of Endologix, check out this story: How Endologix Is Winning Customers Back One Procedure at a Time

  • GenMark Diagnostics

    GenMark Diagnostics' ePlex system was a 2017 Medical Design Excellence Awards Winner in the category of testing and diagnostic products and systems.

    The ePlex system is a sample-to-answer instrument designed to perform multiplex molecular testing for infectious disease diagnostic in high-risk patients. Physicians can quickly and effectively identify bacterial, viral, and fungal infections, as well as antibiotic resistance markers to aid in determining the appropriate treatment.

    The Carlsbad, CA-based company received FDA clearance in 2018 for its ePlex Blood Culture ID – Gram Positive (BCID-GP),  and Fungal Pathogen (BCID-FP)  panels. As of Feb. 28, FDA was still reviewing the company's Gram Negative (BCID-GN) panel but that clearance could come any day now.

    Needham & Co.'s Mike Matson noted in a recent report that the recent regulatory clearances should help drive ePlex system placements in 2019.

  • Glaukos

    FDA approval of the iStent inject Trabecular Micro-Bypass System in June 2018 gave San Clemente, CA-based Glaukos an opportunity to pull ahead in the minimally invasive glaucoma surgery (MIGS) market. Glaukos said the iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal.

    The system includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion. Each iStent inject stent is about 0.23 mm x 0.36 mm, or about one-third the size of the first-generation iStent.

    FDA approved the company's first-generation iStent back in 2012.

    For the most recent MD+DI coverage of Glaukos, check out this story: Glaukos Keeps Its Eye on the Prize at J.P. Morgan

  • Inspire Medical

    Nearly 11 years after being spun off from Medtronic, Inspire Medical stepped forward in 2018 to announce it is going public through a $75 million IPO.

    Inspire has been approved to list its common stock on the New York Stock Exchange under the ticker symbol “INSP.”

    The Minneapolis-based company has developed a neurostimulation device that provides treatment for moderate-to-severe obstructive sleep apnea. The technology is a closed-loop solution that uses an algorithm to continuously monitor a patient’s breathing patterns and delivers mild stimulation to the hypoglossal nerve to maintain an open airway during sleep.

    FDA approved Inspire's device in 2014. The company was formed in 2007 after Medtronic spun out the technology and significant intellectual property portfolio.

    For the most recent MD+DI coverage of Inspire Medical, check out this story: Inspire Puts Sluggish IPO Concerns to Bed with Filing.

  • Insulet Corporation

    Medtech analysts have been pumped about Insulet for a while now. Canaccord Genuity's Kyle Rose released a report on the Billerica, MA-based tubeless insulin pump maker in May 2018 that highlighted several catalysts on the horizon for Insulet, plus results of a physician survey the firm conducted in the space.

    Rose said that while Insulet is faced with an increasingly competitive market, reimbursement wins this year have improved what was "already a fundamentally strong U.S. market position."

    FDA also recently cleared Insulet's Omnipod Dash insulin management system.

    "Our positivity was further reinforced by our survey of 50 endocrinologists that point to increasing patient demand for insulin pumps, a meaningful opportunity for Dash to drive market share gains over the next 18 months (new patient adds and increased utilization), and the importance of Insulet's focus/success on expanding Omnipod market access," Rose said. "In sum, we continue to think [Insulet] remains in the early stages of a transformative 24-month period that will see meaningful global share gains (competitive consolidation, Dash new product cycle, and OUS transition) and significant margin expansion as the company turns profitable in [the second half of the year].

  • Intersect ENT

    Menlo Park, CA-based Intersect ENT is nothing to sneeze at. The company launched its Sinuva Sinus Implant in April 2018, representing a new approach to treating nasal polyp disease in adult patients who have had previous sinus surgery. FDA approved the device in December 2017.

    Sinuva is placed during a routine office visit and it is designed to provide a less invasive treatment option for patients who have previously undergone sinus surgery, yet suffer from recurrent sinus obstruction. The company said the device delivers anti-inflammatory medication directly to the site of the disease.

    The technology differs from Intersect ENT’s Propel Implant. The Propel Contour features a low-profile flexible delivery system to make it easier to access tight areas of the sinus anatomy. 

    “When in the operating room we believe that surgeons will still want to surgically remove the sinus obstruction and use Propel,” Susan Stimson, general manager for Sinuva, told MD+DI.

    For more on the Sinuva launch, check out this story: Sinus Implant Launches During Start of Strong Allergy Season.

    Intersect ENT Inc.
  • Invuity - SOLD

    Invuity, known for its Intelligent Photonics devices used to evenly light surgical cavities, was acquired by Stryker not long after this list was originally published. The deal, which was valued at $190 million, was announced in September 2018 and closed about a month later.

    Invuity's handheld lighting devices are primarily used in breast, orthopedic, and spine procedures, but the company expanded into gynecology in 2016.

  • iRhythm Technologies

    With a wearable device that works and big data that can make a difference, it's easy to see why Needham & Co. included San Francisco-based iRhythm Technologies on its list of most attractive public medtech companies for potential M&A. The company also was a finalist for MD+DI's 2016 Medtech Company of the Year.

    iRhythm's FDA-cleared chest-worn Zio XT patch one-ups the cumbersome Holter monitor by recording patients' heart rhythm continuously for up to 14 days, even in the shower, in order to detect arrhythmias. At the end of the monitoring period, the patient sends the device back to iRhythm, which condenses the information gathered into a report that can help the patient's physician characterize their condition and recommend treatment.

    iRhythm also keeps a repository of all the ECG data it collects and offers quarterly reports to help providers measure utilization and diagnostic yields.

    One medtech analyst that has been fairly bullish regarding iRhythm this year is Canaccord Genuity's Jason Mills. In a May 16, 2018 report, Mills said the publication of the KP-RHYTHM study in JAMA Cardiology gives him even more confidence in the stock. Results from the study, which highlighted the relationship between higher atrial fibrillation (AF) burden in paroxysmal AF patients and a significant increase in stroke risk (by more than three times), exemplify not only Zio’s core competency as the preeminent long-term, continuous ambulatory electrocardiography monitoring device, but also speak to the strength of iRhythm's "competitive moat as a disruptive force in this rapidly changing space," Mills said.

    For the most recent MD+DI coverage of iRhythm, check out this story: iRhythm Finds Its Groove at the Intersection of Cardiology and AI

    iRhythm Technologies Inc.
  • K2M - SOLD

    K2M, a company that developed minimally invasive spine technologies and techniques, was also snatched up by Stryker. The $1.4 billion deal was announced in August 2018 and closed in November 2018.

    The company is known for its Balance ACS platform of products, services, and research designed to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes.

    K2M's Serengeti minimally invasive retractor system (pictured) garnered a Medical Design Excellence Award in 2010 and was included later that year on MD+DI's list of 50 Companies to Watch.

    K2M Holdings Inc.
  • Masimo 

    While it's no surprise that Masimo stands out to medtech analysts as an attractive potential acquisition target, Masimo's management has indicated as recently as August 2017 that it may be on the prowl for an acquisition or two of its own.

    Masimo isn't likely to buy companies that are too similar to itself though. Masimo CEO Joe Kiani told investors during a quarterly earnings call in 2017 that Masimo is more interested in M&A opportunities that are "totally separate from our business" rather than adjacent to it because it wants to create diversification.

    "We're looking for opportunities in big markets" that are estimated to be about $3 billion or $4 billion in size and growing and seeing at or near double-digit growth. We're not looking for [a] $1 billion, $2 billion type of acquisition," Kiani said. "We're looking for what I call fixer-uppers in great neighborhoods."

    And even as Kiani talked about the company's appetite for M&A, CFO Mark de Raad assured investors that R&D is still the lifeblood of the company. Masimo has historically spent more on R&D than most of its competitors, de Raad said, and "there is no reason to assume that's going to change."

    Masimo's Rad-67 handheld pulse CO-oximeter was a finalist in the 2018 Medical Design Excellence Awards in the category of Nonsurgical Hospital Supplies and Equipment.

    The Rad-67 is a handheld pulse CO-oximeter that allows clinicians to obtain noninvasive spot-check measurements, including SpO2 blood oxygen, hemoglobin, perfusion index, and pulse rate. The device features a small size, lightweight design, six-hour battery life, and hi-resolution touchscreen. 

  • Nevro

    Nevro's spinal cord stimulation technology surely checks most, if not all, of the boxes when it comes to what acquiring medtech companies are likely to be looking for (high growth and large market opportunities, differentiated products, and regulatory approvals).

    In a May 2018 report, Canaccord Genuity's Jason Mills pointed out several things he favors about Nevro, and the spinal cord stimulation market in general. Technology like Nevro's offers an alternative to opioids, an issue that is gaining more and more attention in healthcare. Mills also said Nevro has been expanding its sales force to drive more share gain, and the analyst noted the potential for upcoming the company's total addressable market to expand, especially within the peripheral diabetic neuropathy patient population, which he said Nevro's Senza HF-10 therapy is "uniquely positioned to address."

    For the latest MD+DI coverage of Nevro, check out this story: Nevro Excels in Sales, but Misses on EPS Consensus 

    Nevro Corp.
  • Nuvectra

    Another neuromodulation company that made Needham & Co.'s list for attractive potential M&A targets in medtech is Nuvectra. While the Greatbach spinout's technology shows a lot of promise in the space, Nuvectra suffered a regulatory setback last year in both the United States and Europe with its sacral neuromodulation system designed to treat chronic urinary retention and the symptoms of overactive bladder.

    FDA asked the Plano, TX-based company for additional information related to any modifications or changes to its Virtis device, labeling, and manufacturing as well as clarifications of data related to MRI. The company also has been asked to submit clinical study data to the European Union regulatory before it can recommend CE mark approval for the same device.

    For more on Nuvectra's recent regulatory news, see this story: Nuvectra Suffers Painful Stock Drop After Regulatory Update.

  • OrthoPediatrics

    OrthoPediatrics was founded in 2006 to focus on the neglected field of orthopedic implants for children. By that time, implantable orthopedic devices in adults were becoming the norm, but too often, adult implants were modified in the operating room so they could be used in children. The company's founders asked why a more appropriate standard of pediatric care should not be available, too. The founders were composed of orthopedic industry experts in Warsaw, Indiana drawn from DePuy Synthes, Smith & Nephew, and Zimmer Biomet. Their vision was to address the problem of off-label use of adult implants by building a different kind of orthopedic company; a company focused exclusively on pediatric orthopedics and committed to the cause of improving the lives of children with orthopedic conditions.

    And the company has come a long way since its founding. In May 2018, the company's newly launched rigid intramedullary nailing system, the Pediatric Nailing Platform femur system was used to correct a femur that was rotated too far in a 13-year-old girl.

    Capable of addressing trauma and deformity corrections alike, the first surgery performed with the new system represents the culmination of 18 months of development as the company enters the next step in the evolution of its Intramedullary Nailing franchise, OrthoPediatrics said in a press release.

  • Penumbra

    Penumbra is another company on the list that more than meets the criteria that a lot of acquiring medtech companies are after. The company has a broad portfolio of medical devices, including an aspiration-based stroke treatment system that competes with several other devices, including Stryker's Trevo stent retriever.

    The aspiration system creates a low-pressure vacuum to suck a clot out of its location, while the stent retriever uses a mechanism to pull it out. However, both are inserted into a guide catheter, and according to the COMPASS trial, led by Aquilla Turk, director of the stroke and cerebrovascular program at the Medical University of South Carolina, outcomes of each technique result in a "pick 'em" situation for clinicians.

    "If you look at the technique we use with aspiration, it's not a competitor to the stent retriever," Turk said. The trial results showed outcomes of the technique, dubbed ADAPT (A Direct Aspiration, First Pass Technique), were virtually identical to outcomes of thrombectomies performed with the stent retrievers. Turk said he's had many cases in which aspiration opens the affected blood vessel within five minutes of the insertion of the catheter in the groin.

    "We'll try that two or three times and if it doesn't open it, then at that point, through the aspiration catheter, you can put a stent retriever," Turk said. "If you do that approach, and do it in that sequence, we find we are about 95% effectively getting the blood vessels open in a fast and efficient manner."

  • Presbia

    Presbia is focused on the development of the presbyopia-correcting Presbia Flexivue Microlens – a solution for the common age-related loss of the ability to read or focus on near objects. The 3mm diameter lens is implanted in a corneal pocket created by a femtosecond laser. Learn more about the Microlens solution.

    The company said its solution responds to the market’s need for a surgical procedure that is safe, effective, quick, and easy to learn and implement. The Presbia Flexivue Microlens solution relies on surgical equipment already in use at most eye surgery centers. Most distinguishing, the Presbia Flexivue Microlens is designed to be removable, meaning the lens can be removed and replaced without any residual effect on the eye.

    The device has a CE mark in Europe but is not yet FDA approved.

  • Senseonics

    Senseonics’ Eversense continuous glucose monitoring (CGM) system is currently the only CGM available to patients that features an implantable glucose sensor and provides long-term continuous monitoring for up to three months.  Tim Goodnow, the Germantown, MD-based company’s president and CEO, spoke with MD+DI about the Eversense CGM system in June 2018, at the American Diabetes Association’s 78th Scientific Sessions in Orlando, FL.

    “Once a person is diagnosed with diabetes, it’s not curable, but you can manage it effectively and really minimize the long-term effect if you’re very aggressive in managing your glucose control. Diabetes patients already know this, they just want tools and techniques to help them do it easier. They don’t want one more thing to think about. The value of a long-term implantable is it takes the interaction with the sensor off the table,” Goodnow said.

    The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified healthcare provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days.

    For the latest MD+DI coverage of Senseonics, check out this story: Senseonics’ CGM Becomes More Effective with Latest FDA Nod

  • Sientra

    Sientra, a medical aesthetics company, gained traction last year, having received FDA approval in April 2018 of a premarket approval application supplement allowing commercialization of its Opus breast implant products manufactured by Vesta, a Lubrizol Lifesciences company.

    Jeffrey Nugent, chairman and CEO of Sientra, said the approval allows the company to sell its Opus breast implants with an improved manufacturing process that represents a critical milestone for Sientra. 

    "The approval culminates over two years of successful collaboration between the Sientra and Vesta teams.  We now once again have access to a supply of implants to support our plan to regain and grow share in the U.S. breast implant market for both augmentation and reconstruction.  Our decision to manufacture finished goods product prior to approval has positively positioned us to begin meeting customer demand immediately. We will continue our precision-controlled selling strategy through the first half of 2018 as the new Vesta facility scales its manufacturing to full supply capabilities, which we anticipate will occur during the second half of this year." 

    Nugent said the company rebranded its breast products with a name that symbolizes what they represent.

    "We chose the name Sientra Opus, the only brand of silicone gel breast implants and tissue expanders marketed exclusively to board-certified plastic surgeons.  Opus signifies an artist’s best body of work and for our brand, the name evokes excellence, quality, performance, and artistry.  We believe our Opus products provide the true artists with the best tools available to achieve optimal results.”

    But getting the product to this point hasn't exactly been easy for Sientra.

    In September 2015, the company's stock plummeted more than 52% in light of the potential contamination problems and the decision by UK regulatory authorities to halt sales there involving the company's former contract manufacturer Silimed. This in turn triggered a shareholder lawsuit organized by several law firms nationwide. The company also decided to halt U.S. sales of breast implants made by contract manufacturer Silimed.

    A month later there was a fire at one of the facilities used to make its products in Brazil.

    “Since October 2015, the entire Sientra team has been determined to overcome each successive challenge stemming from our former Brazilian manufacturer," Nugent said. "With today’s FDA approval, we have closed the final chapter of our transition and positioned the company with a diversified portfolio of differentiated products to capitalize on significant market opportunities for each of our two core businesses. Overall, we are now poised to continue executing an integrated commercial aesthetics strategy. In the immediate term, we will be leveraging the American Society for Aesthetic Plastic Surgery (ASAPS) annual meetings held later this month to showcase each of our brands. Looking further ahead, we expect 2018 to be another pivotal year in which we deliver meaningful incremental value to our customers, patients, and shareholders.”

  • Tandem Diabetes Care

    San Diego-based Tandem Diabetes Care is another diabetes device maker that has had a lot to celebrate recently. In June 2018 the company announced FDA approval of its t:slim X2 insulin pump with Basal-IQ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia). This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices, the company noted. Tandem plans to launch its new product with the Dexcom G6 CGM integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA in 2018.

    FDA recently approved Tandem's t:slim X2 insulin pump. The approval created a new device category called alternate controller enabled infusion pumps (ACE Pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance.

    The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

  • Wright Medical Group

    In a May 2018 report, Needham & Co.'s Matson noted that Wright Medical Group saw improved revenue growth as strong U.S. lower extremities and international growth improved and U.S. upper extremities growth remained strong. The company saw improved productivity from its U.S. lower extremities sales force, the analyst said, and also addressed its cash needs with $31 million from an insurance settlement and a $40 million increase in its loan agreement.

    "With [Wright's] U.S. lower extremities business on the mend and the capital overhang lifted, we are more positive on [Wright] but maintain our hold rating given our expectation of a large share price increase."

    Whether or not Wright will get scooped up remains to be seen. Meanwhile, Wright is busy on the buying side of M&A. The company announced in August 2018 that it plans to acquire Cartiva for $435 million.

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