Will Tracker-Like Aesthetics Lead to Anti-Nausea Device Bonanza?

EmeTerm courtesy of WAT Medical Enterprise Ltd.
Image of the EmeTerm courtesy of WAT Medical Enterprise Ltd.

A Canadian-Chinese medical device manufacturer is poised to enter a niche market for nausea-fighting neurostimulation with a sleek wrist-worn transcutaneous electric nerve stimulation (TENS) device, providing an alternative to a long-established manufacturer that has just released a redesign of its technology.

Peter Ji, co-founder of Vancouver, BC, and Ningbo, China-based WAT Medical Technology, said there is plenty of room in the nascent therapeutic wearables market for both his firm and Horsham, PA-based Reliefband Technologies to thrive in combating motion sickness, morning sickness, post-operative nausea, and a fairly new malady—nausea caused by exposure to virtual reality technology.

"We don't really see Reliefband as a competitor," Ji said. "They've been in the market a lot longer than us. The anti-nausea market is a large one with a lot of potential."

The market may indeed be sizable. However, device-based therapies for it have not proliferated or enjoyed ownership longevity—for instance, Reliefband's technology was invented in the 1990s by a San Diego firm called Woodside Biomedical, which was acquired by Abbott in 2003. The brand was acquired by Chicago-based Neurowave Technologies in 2006; in 2015, with a $5 million investment from PathoCapital, a specialty healthcare fund headed by former Baxter Healthcare and Ovation Pharmaceuticals CEO Wilbur Gantz (now Reliefband's chairman of the board), it moved to the Philadelphia suburbs.

At the time of the investment, Reliefband said in a statement that "the investment will fuel the consumer market introduction of Reliefband, an FDA-cleared wearable device for the drug-free treatment of nausea."

Reliefband executives did not respond to numerous requests for comment for this story. However, public filings with FDA, a patent infringement suit the company filed in 2008, and promotional material provide a substantive history of the technology, which was originally used by prescription and cleared for over-the-counter use in 1999.

Substantially equivalent

Both company's products have been classified and cleared as Class II devices by the U.S. FDA; in fact, FDA documentation for the WAT Medical EmeTerm, which received approval in April, refers to the Reliefband specifically as the predicate device for which substantial equivalence has been declared. Both work by pulsing energy on the P6 acupuncture point on the underside of the wrist to interrupt nausea signals to the brain. Both feature adjustable rates of stimulation to allow users to use the least amount of therapy necessary.

Proponents of TENS anti-nausea therapy say one of its key appeals is the reduction or elimination of anti-emetic drugs' side effects. However, clinical trial results of the treatment are mixed, with some researchers finding TENS therapy reduces symptoms and can cut drug interactions, and others finding no substantial reduction of motion sickness; meanwhile, both Reliefband and WAT Medical are undergoing clinical and professional evaluation to buttress consumer perceptions.

For example, WAT Medical's Ji said the company is currently conducting studies in Canada and Turkey and would like to initiate studies in the United States; he also said professional reviews by physicians would add gravitas to consumer reviews. Reliefband claims of efficacy, meanwhile, were recently evaluated by the Electronic Retailing Self-Regulation Program, an investigative unit of the advertising industry’s system of self-regulation administered by the Council of Better Business Bureaus. In a statement, ERSP recommended the marketer eliminate any references regarding the specific time in which consumers can expect the product to provide relief and also recommended more evidence will be necessary to back up claims of the technology's overall superiority.

"Although the marketer demonstrated the efficacy of acustimulation (Reliefband) versus one competitive prescription drug for post-operative nausea ERSP further recommended the advertiser discontinue broad comparative superiority messages— expressed, implied or made through testimonials—until it has additional evidence necessary to support such claims," the organization said.

While the products' developers and intended users wait for additional vetted data, aesthetics and ease of use figure prominently in the devices' promotion. The EmeTerm, which lists for $91, won a 2017 award at the iF International Forum Designcompetition; the Hannover, Germany-based organization evaluates more than 5000 submissions from 70 countries every year. Ji said "our goal with the design right now was to keep it simple and intuitive, so one button controls all the functions. And we try to make it look as nice as possible, of course."

Reliefband released a totally redesigned device, Reliefband 2.0, at the 2018 Consumer Electronics show; the device's design changed from a spherical device with multiple indicators and replaceable batteries to a streamlined rechargeable device that resembles leading fitness trackers (the retail price also nearly doubled to $174.99 from its predecessor's $94.99).

One difference in useability between the two is that the EmeTerm does not require the use of any conductive gel; Ji said the device's electrodes were redesigned with inert alloys, "So we basically increased the contact surface area on the metallic parts," he said. "That way we do not need a gel to increase the conductivity."

Depending upon how the devices are perceived by prospective users, industry analysts project annual market growth rates between a steady 3 percent (for motion sickness treatments, including drugs and devices) and a booming 18 percent (for wearable medical devices) over the next four to eight years. WAT Medical's Ji is confident the technology can make solid inroads if it is taken seriously as a treatment option.

"There are a lot of unexplored grounds in neuromodulation that can be covered, and I think we can both benefit if more consumers and doctors accept this as a therapy," he said. "Honestly, I think the market is big enough for both of us."

Ellipse Buy Reheats M&A Activity for Aesthetics Market

Pixabay Ellipse Buy Reheats M&A Activity for Aesthetics Market

Syneron Candela is slated to acquire Ellipse, a medtech firm that develops Intense Pulse Light and laser-based platforms for a wide variety of medical and aesthetic skin treatments. Terms of the deal were not disclosed.

Ellipse's key products include Nordlys, a multi-application, multi-technology IPL and Nd:YAG platform for vascular and pigmented lesions, as well as hair removal. The Nordlys also offers a fractionated 1550 nm handpiece for skin resurfacing. Other products include an IPL-only system used for skin rejuvenation, facial veins and hair removal, as well as a fractional non-ablative laser system used for skin resurfacing.

"The acquisition of Ellipse allows Syneron Candela to strengthen its footprint in the multi-application space and provide our customers a comprehensive portfolio. Syneron Candela's best-in-class laser and energy-based technologies are now coupled with a trusted IPL technology that is well respected by physicians,"  Geoffrey Crouse, CEO of Syneron Candela said in a release.

Wayland, MA-based Syneron Candela’s plan to acquire Ellipse follows substantial M&A activity that occurred in the aesthetic device market in 2017.

The mergers began when Allergan announced it would acquire Zeltic Aesthetics, acompany known for its CoolSculpting System, which reduces fat with a body contouring process based on cryolipolysis, for $2.475 billion.

A day after Allergan made its announcement, Hologic made a $1.65 billion offer to acquire Cynosure, which also offers body contouring.

Attune’s Oversubscribed Round Shows It Resonates with Investors

Courtesy of Attune Medical Attune’s Oversubscribed Round Shows It Resonates with Investors

Attune Medical is really hitting it off with investors. The Chicago-based company, which was once known as Advanced Cooling Therapy, said it has raised about $15.5 million in an over-subscribed series C round.

“This last close of the Series C really occurred because of oversubscription and investor interest in the market,” Keith Warner, Attune Medical’s CEO told MD+DI. The company has really been able to take advantage of that to raise more than it originally targeted.”

The EnsoETM (formerly Esophageal Cooling Device or ECD) is designed to modulate and control patient temperature through a single-use, fully-enclosed system that is inserted into the esophagus. Two lumens attach to an external heat exchange unit while a third, independent, lumen simultaneously allows gastric decompression and drainage, as well as the administration of enteral fluids such as tube feeds and medications in some models.

The financing round will help the company focus on studies for additional indications.

“These funds will help us accelerate the uptick in the market in the critical care market,” Warner said. “As a second point, the funding allows us to increase our exposure to other applications in that temperature management space. Temperature management is proving to be useful clinically in a more diverse set of applications than just critical care.”

He noted that the company is preparing to launch studies looking at hypothermia prevention in the operating room. Long complex surgeries often leave patients hypothermic.

Attune will also look at pursuing further clinical studies and ultimately regulatory clearance for new clinical applications focused on reduction of esophageal thermal injury which can result from cryo- or radiofrequency-based cardiac ablation, a commonly used treatment for atrial fibrillation.

The EnsoETM model for use with enteral feeding was cleared by FDA in January, with an additional clearance for use with Cincinnati Sub-Zero’s Norm-O-Temp Hypothermia System in May 2018. The device received its CE Mark in Europe in 2014, with an expanded indication for use up to 120 hours in 2016 and a CE Mark for use with the Altrix System by Stryker in 2017. The device is also licensed for sale in Canada and Australia.

Nonradioactive Breast Cancer Marking Platform Gains Second Nod from FDA

Nonradioactive Breast Cancer Marking Platform Gains Second Nod from FDA
The Sentimag probe (shown above) is used with both Magseed for tumor localization and Magtrace (shown below) for sentinel node identification. Images courtesy of Endomag.

Most breast cancer patients have some type of surgery to take out their tumors. But that is not sufficient to ensure that all cancer cells are found and removed. “Cancer cells primarily use the lymphatic system to spread throughout the body and are most like to be found in the first draining lymph node, as the node filters out these cells,” said Mathew Stephens, commercial director, Endomag, in an interview with MD+DI. “These ‘sentinel’ nodes are the most likely place to find cancer, and so the surgeon will want to be able to locate that lymph node during surgery.” The node will then be biopsied to see if there are cancerous cells in it.

Surgeons need ways to pinpoint the sentinel nodes, as well as primary tumors that may be too small to be palpable, during surgery to avoid cutting out more tissue than is needed. Current techniques to make the sentinel nodes visible involve radioactive and blue dyes. Radioactive seeds that are detected with a gamma probe can be used to locate primary tumors. But handling radioactive materials comes with its own set of concerns. Stringent regulations, special staff training requirements, and issues with segregating the waste from the operating room can make it difficult to use. Radioactive materials are also limited in their availability, can cause scheduling delays, and can be uncomfortable or painful for patients, according to Endomag.

To avoid these types of concerns, Endomag offers a marking technology that employs a magnetic field. It includes a device called Magseed for tumor localization and one called Magtrace for sentinel node identification. Endomag had received FDA 510(k) clearance for Sentimag/Magseed in 2016, and now the company has just had its PMA approved for Magtrace.

Using ultrasound to guide its placement, Magseed is inserted into the tumor up to 30 days in advance of surgery. It is a 5 x 1 mm device made of paramagnetic steel and iron oxide. The seed is cylindrical with no barbs and is easily visible on mammography and ultrasound. It is supplied in sterile packaging preloaded into an 18-gauge 20-cm-long steel needle.

Magtrace is made of tiny particles that are the same size as cancer cells and have a special coating that allows them to flow easily through the lymphatic system. They are filtered in the same way by the sentinel node, allowing the surgeon to locate that specific tissue, said Stephens. The tracer is a dark brown aqueous suspension of organically coated, superparamagnetic iron oxide particles that dissipate naturally in the body. Localization can start after only 20 minutes following injection into the subareola region of the breast, but it can also be given up to seven days in advance of the procedure.

Both devices are used with the company’s Sentimag probe, which generates an alternating magnetic field that transiently magnetizes iron oxide particles within Magseed and Magtrace. The magnetic signatures of the devices are then detected by the probe. The Sentimag unit displays a numerical count and produces an audio tone, both of which are related to the strength of the magnetic field and therefore the distance of the seed or tracer from the detector probe.

Magtrace has already been used in Europe for five years in more than 30,000 procedures.

“After 18 months of using the Sentimag platform with Magseed for lesion localization, we’re really excited to add the sentinel node biopsy capability with Magtrace. Being able to carry out both seed localization and sentinel node biopsy with one instrument made this the only option for us,” stated Michael Alvarado, professor of surgery, UCSF, and principal investigator for the U.S. Magtrace trial, in Endomag’s press release.

A Rival to the Renal Denervation Therapy Procedure?

Pixabay A Rival to the Renal Denervation Therapy Procedure?

Vascular Dynamics is taking a different approach in its bid to treat patients with drug-resistant hypertension. While firms like Medtronic have gravitated toward using renal denervation to treat drug- resistant hypertension, Vascular Dynamics is developing a stent-like application to treat the condition, which effects more than 100 million patients in the U.S.

The Mountain View, CA-based company said it has enrolled the first patients in a pivotal trial. The company’s CALM-2 study is designed to establish safety and efficacy of the endovascular baroreceptor amplification (EVBA) procedure using the MobiusHD device as a treatment for drug-resistant hypertension.

“This is an endovascular neuro-receptor reflex activation device that is a permanent carotid stent-like implant,” Gregg Stone, MD, Co-Principal Investigator of the CALM-2 trial and Director of Cardiovascular Research and Education for NewYork-Presbyterian/Columbia University Medical Center and Co-Director of Medical Research and Education at the Cardiovascular Research Foundation,toldMD+DI.

The CALM-2 trial is targeting enrollment of up to 300 patients at leading institutions across the U.S. and Europe.

“[The technology] has been used in a modest number of patients and open-label studies,” Stone said. “It has been shown in patients with resistant hypertension to be quite remarkably effective. Now the question is can we show the same results in a well-designed sham-controlled trial. We’re very excited about the potential of this device being able to play an important role in the treatment of those patients who have really very few clinical options.”

At one point renal denervation seemed as if it was the hottest approach device companies were taking toward treating drug-resistant hypertension in patients. Earlier this year, Medtronic renewed its interest in renal denervation by gaining FDA approval to launch a pivotal trial testing the Symplicity Renal Denervation system.

The measure came after the Dublin-based company’s Symplicity Renal Denervation system failed to meet its primary endpoint in SYMPLICITY HTN-3 trial. However, the device did meet its safety endpoints.

The negative outcome of the SYMPLICITY HTN-3 trial caused many companies to abandon the renal denervation hype train.

Stone said that there was some pressure on Vascular Dynamics for its technology but noted that things aren’t as gloomy for renal denervation or approaches using devices to treat drug- resistant hypertension as they were in the past.

He noted that there are three sham trials that have had positive results using renal denervation. He added that companies are learning from the mistakes of past trials and are more rigorously designing clinical studies.

“It was a shock to everybody that the Symplicity Hypertension treatment [failed to meet its primary endpoint], but it’s also been a wakeup call,” Stone said. “They thought it was going to be such a wildly positive study, but they didn’t consider all of the sources of variability. We’ve learned and have scrutinized all of [Medtronic’s] results – what they did right; and what they could have improved.”

10x Genomics Seeks to Take Larger Piece of Genomics Market

Pixabay 10x Genomics Seeks to Take Larger Piece of Genomics Market

With the genomics market slated to be worth $24 billion in the next five years, 10x Genomics is moving forward with plans to boost its offerings in the space. The Pleasanton, CA-based firm said it is acquiring Epinomics, a specialist in the growing epigenetics space, for an undisclosed sum.

The acquisition will give 10x Genomics ATAC-seq technology and fundamental IP to accelerate discoveries and further research in epigenomics, paving the way for a new understanding of disease, diagnostics and therapeutics.

Epinomics’ ATAC-seq technology is an approach to measure and understand the epigenome.

“Our goal is to accelerate science and enable our customers to see biology they could not see before,” Serge Saxonov, CEO and co-founder of 10x Genomics said in a release. “[The] acquisition gives us a strong team, IP and technology that has been enthusiastically validated by customers. It provides a foundation for powerful new products and positions us well to become the leader in epigenomics.”

Menlo Park, CA-based Epinomics was founded in 2013, just a year after 10x Genomics was launched.

According to its website, Epinomics decodes the programming of the genome to drive personalized medicine, using big data analytics and proprietary epigenomics technologies to impact drug development and clinical applications.

“With Epinomics joining 10x Genomics, single cell epigenetics will now be available to a broader base of investigators across academic and commercial organizations,” Howard Chang, professor of Dermatology and Genetics at Stanford University School of Medicine, co-inventor of ATAC-seq and a scientific co-founder of Epinomics, said in a release. “The innovations coming out of this acquisition will propel the genomics field forward.”