Fractyl Labs launches Revita DMR diabetic treatment study



Fractyl Laboratories said today it launched the Revita-2 clinical trial of its Revita DMR procedure in orally-treated type 2 diabetes patients with poorly controlled disease.

The company said that it has enrolled the 1st patient in the trial at a European center participating in the study.

The Revita DMR is a minimally invasive procedure designed to ablate and ‘rejuvenate’ the duodenum (the 1st part of the intestine) in order to alter glucose metabolism, the Lexington, Mass.-based company said.

“Untreated insulin resistance can lead to more severe diseases including fatty liver disease and NASH. The initial clinical data of Revita DMR is encouraging, and there is enormous need for treatments that can change the course of these metabolic diseases,” Jacques Devière of Brussels’ Hôpital Erasme said in a prepared statement.

The Revita-2 clinical trial is a randomized, sham-controlled, blinded study at multiple centers in Europe and will include 3-month glycemic and hepatic endpoints, the company said.

“The clinical data we have gathered to-date suggests Revita DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications. We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials,” co-founder & CEO Dr. Harith Rajagopalan said in a press release.

Novartis’ Ultibro Breezhaler tops corticosteroid for COPD in head-to-head study


NovartisNovartis (NYSE:NVS) said today that a new analysis of its head-to-head Flame trial showed that inhaled corticosteroids may not be necessary in some chronic obstructive pulmonary disease patients with high blood eosiophil counts.

The data demonstrated that the company’s Ultibro Breezhaler provided better or similar benefits compared to Seretide, an inhaled corticosteroid, in COPD patients regardless of eosiophil count. These results contrast with previous work suggesting better outcomes with inhaled corticosteroids for patients with high eosinophil counts.

Get the full story at our sister site, Drug Delivery Business News.

Symic Bio raises $30m for peripheral vein graft failure therapy


Symic BioSymic Bio said yesterday that it raised $30 million in a Series B financing round, led by existing investors and HEDA Ventures.

Funds from the round are slated to support the company’s clinical programs, including a drug designed to prevent peripheral vein graft failure, SB-030, and a therapy for pain management of osteoarthritis of the knee, SB-061.

The San Francisco-based company also said yesterday that it plans to launch a Phase III trial of SB-030 in 2018, following a pre-investigational new drug meeting with the FDA. Supported by interim results from the Phase I/IIa Shield study, the regulatory watchdog recommended that the company move forward with a single Phase III registration study.

Get the full story at our sister site, Drug Delivery Business News.

Anika touts Phase III data for Cingal knee therapy

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  • Philips, ResMed tout collaborative home ventilation therapy COPD study results


    Philips, ResMed

    Royal Philips (NYSE:PHG) and ResMed (NYSE:RMD) today touted results from a collaboratively-supported clinical trial exploring the use of home noninvasive ventilation with oxygen therapy on patients with chronic obstructive pulmonary disorder, which indicated improved survivability and prolonged time to readmission.

    Results from the study were published today in the Journal of the American Medical Association.

    “Patients with severe COPD and persistent hypercapnia have historically had limited therapy options available to them and outcomes have generally been poor. The trial suggests that combining home oxygen and home non-invasive ventilation therapy can reduce hospital readmissions while maintaining patients’ quality of life, which will drastically change the way we approach COPD treatment worldwide. We are looking forward to hopefully decreasing the mortality and readmission rates that result from severe COPD with further research,” Dr. Nicholas Hart of London’s St Thomas’ Hospital said in a prepared statement.

    The 116-patient, 12-month study aimed to explore the effect home non-invasive ventilation and oxygen therapy had on time to readmission or time to death in patients with persistent hypercapnia after an acute COPD exacerbation, compared to those treated with home oxygen therapy alone.

    A total of 64 patients in the trial completed the 12-month study period, with a median time to readmission or death of 4.3 months for those treated with home NIV and oxygen therapy versus 1.4 months for those on home oxygen alone, according to study results.

    For patients treated with home NIV and oxygen therapy, the 12-month risk of readmission or death was 63.4%, with patients treated with home oxygen therapy alone at 80.4%.

    After 12 months, 16 patients in the home NIV and oxygen therapy had died, versus 19 in the home oxygen therapy only group, according to study results.

    “This study shows that home non-invasive ventilation is a potent, therapeutic tool that clinicians can use to help keep patients with advanced COPD out of the hospital. We hope that this will, in turn, allow them to lead healthier and more active lives at home. These findings add considerably to our knowledge of this highly prevalent and debilitating respiratory disorder, and are expected to greatly influence how clinicians care for patients with COPD on long-term oxygen therapy,” Philips chief medical liaison Dr. Teofilo Lee-Chiong Jr. said in a press release.

    “This trial adds decisively to the growing body of evidence supporting the broader use of non-invasive ventilation for patients with COPD. Just knowing NIV can help cut re-hospitalization or death risk in half is a game changer,” ResMed chief medical officer Dr. Carlos Nunez said in a prepared statement.

    CytoSorbents touts Refresh trial study data

    CytosorbentsCytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery.

    Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week.

    The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids.

    The prospective, randomized trial looked to evaluate the safety and feasibility of the CytoSorb in treating deadly inflammation in critically-ill and cardiac surgery patients between 18 and 80 years.

    Results from the study indicate that valve replacement surgery was the highest risk procedure for peak plasma free hemoglobin, and that treatment with the CytoSorb increased reductions in peak pfHb levels by 26% at 3.5 hours and 38% at 4 hours. Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery, according to CytoSorbents

    The company said that the trial achieved its primary safety endpoint with a favorable adjudication of all serious adverse events, and no significant differences in the rate of adverse events or serious adverse events at 30 days. No unanticipated adverse device effects were reported.

    “We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery.  Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications.  The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field.  In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy,” principal investigator Dr. Joseph Zwischenberge of the University of Kentucky College of Medicine said in a press release.

    In January, CytoSorbents and  Fresenius Medical Care (NYSE:FMS) said that they expanded the terms of their partnership and added a co-marketing agreement for the CytoSorb blood absorber in countries where the therapy is available.

    InVivo says 2 Inspire patients reverted to original injury scale, posts solid Q1

    InVivo Therapeutics

    InVivo Therapeutics (NSDQ:NVIV) this week said that 2 neuro spinal scaffold trial patients who had reportedly improved have reverted to their original injury state. The company also released 1st quarter earnings which beat the Street, but still saw shares fall.

    The company said that a patient it had announced in January had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury was recently assessed to have reverted back to a complete AIS A spinal cord injury.

    A separate patient, which the company said in March had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury, was recently assessed to have been reverted back to a complete AIS A spinal cord injury.

    “The AIS grade improvement rate observed thus far in the Inspire study compares favorably to the natural history of spinal cord injury. We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of Inspire,” CEO & chair Mark Perrin said in a press release.

    The company said that of the 14 patients in the Inspire trial, 8 have reached the study’s 6-month primary endpoint, with 5 of those having received an AIS grade improvement compared to baseline.

    The Cambridge, Mass.-based company posted losses of $6.4 million, or 21¢ per share, seeing losses grow 3.5%. Losses per share came in just under the consensus on Wall Street, where analysts had expected to see losses of 22¢ per share.

    “In the 1st quarter, we continued to make significant progress at InVivo and with the Inspire study. By early April, we had enrolled four new patients into the Inspire study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the Inspire study,” CEO Mark Perrin said in a prepared statement.

    Shares in InVivo dropped today nearly 15%, down 50¢ at $2.90 at close.

    7 medtech stories we missed this week: May 5, 2017

    medtech stories missed

    [Image from]

    From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning.

    1. Biomerics opening new corporate HQ

    Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The new facility will be 230,000 sq. ft and will be located in the International Center. It will have corporate offices, engineering offices, research and development labs and cleanroom manufacturing. Biomerics is expected to invest $38.5 million in the expansion and add more than 380 jobs over the next 8 years. It is expected to be completed during the second quarter of 2018 and plans to be FDA and ISO-13485 registered for medical device manufacturing.

    2. Refocus completes 1-year follow-up for clinical trial

    Refocus Group announced in a May 4 press release that it has successfully completed a 12-month follow-up on the 360 patients in its VisAbility Micro-Insert System for presbyopia clinical trial. The next step for Refocus will be preparing for Pre-Market Approval submission to the FDA. The VisAbility Micro-Insert System is the first presbyopic procedure performed outside the line-of-sight of the eyes that is designed to restore vision without the potential of compromising distance vision or depth perception.

    3. Glytec touts study

    Glytec’s eGlycemic Management System study results show that the system has a 19% reduction in average daily blood glucose between admission and discharge, according to a May 4 press release. The eGlycemic Management System allows hospitals to achieve the basal bolus standard of care for subcutaneous insulin therapy. The study also showed that there was 0% severe hypoglycemia while receiving the target blood glucose of 140-180 mg/dL at every meal and bedtime. Glycemic data from 1,687 non-critically ill patients treated with subcutaneous insulin therapy between July 2016 and January 2017 were used in this study. It was presented at the American Association of Clinical Endocrinologists 26th Annual Scientific Clinical Congress.

    4. Mevion, medPhoton ink deal to integrate ImageRing, S250i

    Mevion Medical Systems and medPhoton announced in a May 2 press release that they have entered a strategic agreement to integrate ImagingRing with the Mevion S250i. The ImagingRing is a cone beam computed tomography system for image guidance and the S250i is a pencil-beam scanning proton therapy system. Mevion and medPhoton hope to provide simplicity of workflow and more precise and efficient treatment delivery by adding integrated cone beam imaging to in-room image guidance capabilities.

    5. Accuray touts breast cancer treatment study

    Accuray announced that results from its phase I clinical trial for early stage breast cancer patients being treated with CyberKnife System have been released, according to a May 2 press release. The study showed that there was no recurrences or distant metastases at a follow-up of 26 months. More than 95% of patents and 100% of physicians rated prognosis as excellent or good after two years. The purpose of the trial was to study the maximum tolerated dose of 5 fraction stereotactic body radiation therapy for partial breast irradiation for treating early stage breast cancer after receiving a lumpectomy. Patients treated with CyberKnife System received non-isocentric and non-coplanar radiation beams had a follow-up every 3 months for a year and then a follow-up every 6 months for the next 4 years.

    6. RAPS expands European footprint

    The Regulatory Affairs Professionals Society is expanding its European presence, according to an April 20 press release. The European member base for RAPS has grown by almost 19% to more than 1,500 members across 29 countries. RAPS also plans to invest more than 2 million Euros over a 3 year period to implement strategic growth in Europe to launch new events and resources for regulatory professionals in the region.

    7. Neural Analytics opens European office

    Neural Analytics is opening a new European office based in Hamburg, Germany, according to an April 24 press release. Since the company recently received CE Mark for its Lucid System, Neural Analytics wants to enhance its presence in Europe. Neural Analytics is a medical device company that develops and commercializes technology to measure, diagnose and track brain health.

    Here’s what we missed last week.

    Why is clinical research so messed up and how can it be fixed?

    From left: Dr. Michael Kolodziej of Flatiron Health, Dr. Gregg Shepard of Tennessee Oncology, Dr. James Hamrick of Flatiron Health, Dr. Cary Presant of City of Hope Medical Center, Melissa Pool of the Center for Cancer and Blood Disorders

    Dr. Michael Kolodziej was set to moderate a talk on developing a new infrastructure for conducting clinical trials with cancer patients. Instead, the former lead of Aetna’s oncology program and currently national medical director for New York-based health IT company Flatiron Health took his seat, looked at the panel, and then announced to the crowd he was renaming the talk.

    “Why is clinical research so messed up?” he asked. “And how can we fix it?”

    Kolodziej’s made his presentation, which included four other oncology experts, during the Association of Community Cancer Center’s 43rd annual meeting in Washington D.C. this week. But the reason for changing the name of this talk to the two questions Kolodziej asked quickly became apparent to the audience. After all, there’s no point in talking about a new infrastructure for clinical trials without first tackling their current troubles.


    Narrow eligibility criteria, financial feasibility, and the impediment of sheer geography are three problems that repeatedly reared their heads during the 45-minute discussion.

    For Melissa Pool, a registered nurse and clinical research director at the Center for Cancer and Blood Disorders near Dallas, the geography angle was an early sticking point, especially in a state that’s as large as Texas.

    “The difficulties we have are getting clinical trials out to rural communities,” she said.

    Dr. Cary Presant of the City of Hope Medical Center near Los Angeles, Calif., added that part of the current challenge of conducting clinical trials is just finding appropriate trials workable at particular community sites. Presant’s group currently has about four sites with two staff at each prepared to do clinical trials. But financial feasibility remains a question in a way it isn’t for a hospital or large medical center that has the full-time staff and the resources to conduct trials.

    “We find that the amount of discretionary funds to be able to do clinical trials is rapidly diminishing,” Presant said. “Unless you have a large practice, clinical trials might be a loss leader.”

    There’s also something to be said about finding the perceived “perfect patient” to participate oncological trials.

    “At the point of care of enrolling patients, the number one barrier is the availability of a trial to fit that patient and narrow eligibility criteria,” said Dr. Gregg Shepard of Tennessee Oncology, a large oncology group with about 100 physicians.

    Of course, the whole point of conducting clinical trials is to test the efficacy of new drugs or treatments, which might be a boon to cancer patients willing to take risks in the course of their treatment programs.

    But it’s often more difficult to enroll most cancer patients in clinical trials. Present said many drug companies want patients without comorbidities or without prior cancer. Most cancer patients do have comorbidities that they are treating in tandem with their cancer.

    The overarching problem, it seems, is that clinical trials in their current state aren’t exactly representative of the population of people in the U.S. who have cancer.

    Where there does appear to be some hope for the future of clinical trials is in the continuing digitization of health, something that Dr. James Hamrick, a practicing physician with Kaiser Permanente Georgia and senior medical director for Flatiron Health touched on. The data that doctors enter at the point of care, the routine that goes into all cancer patient encounters, can be harnessed to guide clinical trials. This can be done in a retrospective way — by gathering patient data in the aggregate, and then analyzing it to get a real-time, big-picture sense of cancer care in the U.S. It can also be done in a prospective way, by using the data to inform whether eligibility criteria of future trials should be loosened.

    “It’s one of the promises of the digitization of healthcare,” Hamrick said. “It’s also part of the implicit bargain we make with patients when we click away on computers in the exam room with patients. There’s an assumption that the data we’re putting into the computer is going somewhere and being used to help other cancer patients.”

    Using medical data will never replace the randomized clinical trial, Hamrick said. But with data, doctors in the future can stay one step ahead of trials by understanding who among their patients would be eligible for them. In a talk filled with important examinations of problems, the angle on healthcare data provided a spot of hope for reforming how clinical trials are done in the future.

    Photo: From left: Dr. Michael Kolodziej of Flatiron Health, Dr. Gregg Shepard of Tennessee Oncology, Dr. James Hamrick of Kaiser Permanente, Dr. Cary Presant of City of Hope Medical Center, Melissa Pool of the Center for Cancer and Blood Disorders

    Photo: Andrew Zaleski

    7 medtech stories we missed this week: March 24, 2017

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    From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning.

    1. Viveve Medical closes public offering

    Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions.

    2. Masimo receives CE Mark for Rad-97 Pulse CO-Oximeter

    Masimo announced that it received CE Marking for its noninvasive blood pressure measurements from its Rad-97 Pulse CO-Oxumeter and connectivity hub, according to a March 20 news release. Rad-97 allows clinicians to measure arterial blood pressure in adults, pediatric and neonatal patients. It measures using 3 measurement modes: spot-check, automatic interval and stat interval. The built-in port lets clinicians connect a blood pressure cuff inflation hose right on the Rad-97. It also enables easy and automatic charting of blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin and other noninvasive parameters. The device has WiFi and Bluetooth connectivity that allows the device to connect to other devices that are nearby. With its user-friendly multi-touch navigation, clinicians can customize the high-resolution, 1080p HD color display to what they need.

    3. Glaukos announces reimbursement win

    The opthalmic medical technology company Glaukos Corp. has announced that the Current Procedural Terminology (CPT) Editorial Panel of the American Medical Association has given it a 5-year extension to 3 Category III CPT codes that describe insertion of aqueous drainage devices into the anterior chamber of the eye during micro-invasive glaucoma surgery, according to a March 16 news release. Physicians and other healthcare providers use CPT codes to report and receive Medicare reimbursement for services. The 3 CPT codes that received an extension are 0191T, 0253T and 0376T, all of which deal with the iStent device.

    4. DiamiR wins $2.75 million grant for Alzheimer’s biomarker diagnostic device

    DiamiR announced in a March 15 news release that it was awarded a $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the National Institute on Aging and the National Institutes of Health. The grant is going toward supporting the development of DiamiR’s targeted diagnostic technology that analyzes brain-enriched microENA biomarkers in plasma to detect Alzheimer’s disease. The grant will stretch over a 3 year period and builds on to the company’s earlier studies that received SBIR Phase I and SBIR Phase II grants.

    5. Flowonix and Cerebral Therapeutics launch clinical trial

    Flowonix and Cerebral Therapeutics announced that the first patients of its clinical trial have had the Prometra implanted, according to a March 14 news release. The clinical trial, called ADDRESS, is the first multi-center dose ranging clinical study that evaluates intracerebroventricular (ICV) delivery of the drug valproate in patients who have focal seizures and have a temporal lob onset with to without secondary generalization. The study includes 9 patients who will undergo this treatment and will receive the valproate from the Flowonix Prometra II Programmable Pump.

    6. Bonesupport extends U.S. bone Cerament distribution deal

    Bonesupport has extended the terms of its U.S. distribution agreement with Zimmer Biomet, according to a March 14 news release. Zimmer Biomet will continue to have exclusive rights to Sonesupport’s Cerament Bone Void Filler designed for orthopedics, trauma and foot and ankle indications in the U.S.

    7. Ortho Clinical Diagnostics and Astute Medical extend partnership

    Ortho Clinical Diagnostics has expanded its agreement with Astute Medical for its NephroCheck Test distribution, according to a March 13 news release. The NephroCheck Test is a biomarker-based test that asses the risk for acute kidney injury. This new agreement gives Ortho Clinical Diagnostics the distribution rights in more European countries. Astute Medical gave Ortho a license to develop and market the NephroCheck Test in the U.S. and certain countries in Europe in 2014.

    Here’s what we missed last week.