Aegea Medical raises $17m, touts 3-year adaptive vapor ablation pivotal results

Aegea Medical

Aegea Medical said this week it raised $17 million in a new financing round and released three-year follow-up data from the pivotal study of its Adaptive Vapor Ablation technology designed for use in endometrial ablation procedures.

The funding round was led by Solas BioVentures and its affiliates, with funds slated to support the company’s PACE II trial exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures, the Menlo Park, Calif.-based company said.

Funds from the round will also support the 2019 commercial launch of the company’s next-gen Adaptive Vapor Ablation system, Aegea Medical said.

“Aegea’s Adaptive Vapor Ablation technology offers physicians and patients a simple, elegant and safe treatment for treating a complex, underserved condition. The importance of being able to re-access the uterine cavity after endometrial ablation cannot be overstated. Aegea’s unique ablative medium has the potential to preserve less invasive options for patients. We believe we are just beginning to see the technology’s full potential, and we have confidence in its ability to become the new standard of care for treating menorrhagia,” Solas BioVentures co-founder & managing partner Dr. David Adair said in a prepared statement.

“We are fortunate to have found a partner in Solas BioVentures that truly appreciates our mission to provide patients with a natural treatment option that relieves their symptoms and restores their lives. This funding is an important milestone towards the commercialization of our next-generation Adaptive Vapor Ablation system, as well as research into the feasibility of preserving uterine cavity access following treatment,” Aegea Medical prez & CEO Maria Sainz said in a press release.

The company also released three-year results from the pivotal Aegea vapor system study, with results presented at the AAGL Global Conference on Minimally Invasive Gynecologic Surgery in Las Vegas.

Results from the 155-patient study, conducted at 15 sites in the U.S., Canada, Mexico and the Netherlands, indicated that the 120-second endometrial ablation was safe and effective, with 95% of patients reporting normal menstrual bleeding or no menstrual bleeding.

Data also indicated that 92% of patients reported being very satisfied or satisfied with the procedure, and 95% said they would recommend it.

“We are very encouraged by these positive data, as they show that the results of Adaptive Vapor Ablation stand the test of time. These three-year follow-up data should assure physicians and patients that our innovative and natural vapor-based treatment will successfully deliver sustained safe and effective outcomes including improved quality of life,” Sainz said in a prepared statement.

“These results give me great confidence in Aegea’s Adaptive Vapor Ablation procedure. It’s safe and effective, and it delivers the long-term outcomes we are looking for as physicians. I believe Adaptive Vapor Ablation is a valuable new option for treating women with menorrhagia,” Aegea pivotal study principal investigator Dr. Mark Levie of the Albert Einstein College of Medicine said in a press release.

Late last month, Aegea Medical said that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.

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Xeris Pharmaceuticals touts data for glucagon auto-injector

Xeris Pharmaceuticals - updatedXeris Pharmaceuticals (NSDQ:XERS) touted data this month for its ready-to-use glucagon auto-injector, highlighting the device’s efficacy and usability.

The Chicago-based company’s rescue pen is under review for approval by the FDA as a treatment for severe hypoglycemia in people with diabetes.

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

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Baxter touts Hemopatch, Floseal study results

Baxter

Baxter (NYSE:BAX) today presented results from studies of its Hemopatch and Floseal products, touting reductions in costs and hospital stays in both trials.

Results from studies of the devices were presented this week at the International Society for Pharmacoeconomics and Outcomes Research Europe 2018 meeting, the Chicago-based company said.

In a retrospective observational analysis exploring pancreaticoduodenectomies which used the company’s Hemopatch hemostatic-sealant, investigators in Spain found that the device “might be an effective and cost-beneficial additional treatment compared to the Standard of Care alone.”

Results indicated that the use of the Hemopatch lowered complication rates, reducing postoperative pancreatic fistula rates by 23.1%, biliary fistulas by 7.7% and hemorrhages by 7.7%, Baxter said. The use of the device also reduced hospital stays by a mean of 4.8 days and reduced costs by approximately $10,676 or 23% per-patient.

In a separate study analyzing retrospective data on 15,105 propensity-matched pairs of spinal surgeries in the US, researchers found that the use of Floseal alone was associated with fewer blood transfusions, lowered blood-related complications, shorter hospital stays and shorter surgical procedures.

The study compared the cases in which Floseal was used as the sole topical adjunctive hemostat as compared to those where Floseal and other topical hemostats were used.

Researchers in the study developed a cost consequence model to calculate cost savings associated with better outcomes and lowered resource uses, Baxter said. Results indicated cost reductions of $2,445 per spinal procedure.

“Advancing the science and understanding of issues facing patients and hospitals worldwide is a priority for Baxter. The findings shared this week provide real-world evidence for how clinicians may help improve clinical outcomes while increasing hospital efficiency,” medical affairs VP Dr. Dheerendra Kommal said in a press release.

Late last month, Baxter saw shares slip in pre-market trading after the healthcare giant posted third-quarter sales that missed the consensus forecast on Wall Street and cut its sales outlook for the rest of the year.

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Philips launches below-the-knee PAD trial for drug-coated balloon

PhilipsPhilips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon.

The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia.

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

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Pilot trial of Abiomed’s Impella as heart attack treatment meets endpoints, pivotal to follow

Abiomed's Impella RP

A pilot trial exploring the use of Abiomed‘s (NSDQ:ABMD) Impella heart pump as a treatment for reducing the severity of heart attacks has met its primary safety and feasibility endpoints, clearing the way for a pivotal trial, according to primary investigator Dr. Navin Kapur.

Results from the pivotal, if successful, could “change the paradigm of heart attack management,” Kapur told MassDevice.com in an interview.

Data from the pilot trial were announced today at the AHA Scientific Sessions 2018 in Chicago.

“We’ve now demonstrated for the first time that [left ventricle] unloading, using the ImpellaCP device with a 30 minute delay before reperfusion is safe and feasible,” Kapur said, commenting on the pilot trial. “What we also learned was that among patients who have larger heart attacks, there was a significantly lower infarct size.”

Even more importantly, the treatment could improve outcomes for heart failure patients.

“If we can change infarct size by 5%, we think that this will reduce the global burden of heart failure due to heart attacks and will also improve not only short term mortality, but improve long term mortality for patients who are coming in with a heart attack. And that’s really the central goal of both the pilot and the pivotal trial,” Kapur said.

For every 5% increase in heart damage after a heart attack, there’s a relative 20% increase in heart failure hospitalization at one year, and a 20% increase in mortality, Kapur said.

“There’s a significant need in public health for trying to reduce heart attack size for patients who are coming in, despite using contemporary approaches,” Kapur said.

Blocked arteries reduce the amount of oxygen supplied to the heart, Kapur said, so in normal treatment, opening the arteries to improve myocardial oxygenation has been a primary concern. But previous research has suggested that instead of simply restoring oxygen supply by opening arteries, myocardial oxygen demands could also be lowered through reperfusion, or reducing the work the heart has to do – with something like Abiomed’s Impella pump.

In his own research, Kapur said that he’s found that reperfusion works best with a 30 minute delay, leaving the device in and functioning while the arteries are blocked, before opening any arteries.

“We’ve spent the last six to eight years understanding the mechanism for why delayed reperfusion in the setting of an unloading pump seems to work. And there’s a number,” Kapur said.

Kapur and he and his team published research in the Journal of the American College of Cardiology in August exploring the mechanism, and that the pilot study aimed to explore the safety and feasibility of the technique.

In the pilot trial, dubbed The Door to Unload, researchers explored the mechanical benefit of delayed reperfusion in treating patients who suffered from a heart attack. Investigators enrolled a total of 50 patients, half of which received left ventricle unloading with the Impella followed by immediate reperfusion, while the other half received a 30 minute delay to reperfusion, Kapur said.

Safety endpoints in the trial included any increase in major adverse cardiovascular or cerebrovascular events and an increase in infarct size amongst those in the delayed reperfusion arm.

Results from the phase one safety and feasibility trial indicated a 100% successful implantation and unloading rate with the Impella, Kapur said.

Data indicated no significant difference the rate of major adverse cardiovascular or cerebrovascular events among arms, and found infarct size that was smaller than what was seen in previously published studies. Delaying reperfusion had no effect on infarct size either, Kapur said. Patients were examined at three to five days and thirty with cardiac magnetic resonance imaging, he added.

An additional analysis, which explored patients who experienced larger heart attacks, found that unloading and delayed reperfusion resulted in a statistically significantly lowered infarct size, normalized to the area of risk, as compared to unloading and immediate reperfusion.

“And the reason why this is important is because the purpose of the pilot was to inform the development of the pivotal study,” Kapur said.

The pivotal is slated to compare standard-of-care treatment, which takes into consideration only door-to-balloon time, against patients treated with delayed reperfusion using the Impella pump.

Kapur said he believes that results from the trial, if successful, could be disruptive, as it could suggest that unloading treatment with the Impella device is a therapy in itself.

Beyond the pivotal, Kapur said he sees a lot of opportunity to explore other angles, including other therapies or treatments to engage in during the 30 minute delay.

“What do you do during those 30 minutes? Do you give drugs that would potentially be more beneficial in reducing infarct size?” Kapur said.

Earlier this month, Abiomed posted fiscal second-quarter numbers that shredded the consensus forecast and raised its outlook on the rest of the year, sending share prices up sharply today.

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Cardiva touts results from pivotal Vascade MVP vascular closure device trial

Cardiva Medical

Cardiva Medical today released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints.

The results from the AMBULATE trial were presented today at the American Heart Association’s annual Scientific Sessions by Texas Cardiac Arrhythmia Institute exec medical director Dr. Andrea Natale.

The Vascade system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said.

The device functions by placing a collapsible mesh disc against the inner vessel wall to stop bleeding followed by a collagen patch and the removal of the mesh disc, the company said. The collagen patch is designed to expand, seal and stop bleeding and is later absorbed by the body.

In the trial, investigators examined data from 204 patients who underwent arrhythmia ablation procedures. Each patient in the trial had three or four mid-bore femoral venous access sites and were randomized to either receive treatment with the Vascade MVP system or using manual compression, which is the current standard of care.

The study met its primary and secondary endpoints of time to ambulation, reductions in total procedure time, reduced time to discharge eligibility, improved patient satisfaction and reduction in the use of opioid pain medications, Cardiva said.

Patients treated with the Vascade MVP system showed a median reduction of 3.9 hours of time to ambulation, or time for patients to get to their feet and walk following vessel closure. The use of the Vascade system was also associated with a 3.7 hour reduction in time from procedure completion to walking, and resulted in a mean reduction in time for patients to be eligible for discharge by 3.4 hours.

Patient satisfaction for those treated with the Vascade was reported as being 63% higher than those treated with the standard of care, and 58% fewer patients treated with Cardiva’s device used opioid-class medications following their procedure, the company reports.

“The feedback from our patients and staff was extremely positive with Vascade MVP during the study. Patients with previous procedures noticed a significant improvement in their level of comfort due to the much shorter bed rest time, and the time saved overall enabled us to implement a new more efficient workflow in the hospital. Additionally, there was a substantial decrease in the use of post-procedural pain medications in patients receiving the Vascade device. This type of innovation will be particularly important as demand for these procedures continues to grow,” Dr. Natale said in a prepared statement.

“Vascade MVP and the AMBULATE pivotal study represent Cardiva’s commitment to innovation that improves the post-procedure experience for patients undergoing cardiac ablation. The impressive results reported today mark a major milestone in that effort. We are grateful to the investigators, their research teams, and their patients for making the AMBULATE study possible,” CEO John Russell said in a press release.

In April, Cardiva Medical said that it won expanded indications from the FDA for its Vascade vascular closure system, now cleared for use in 5-7F femoral venous closures in addition to arterial closure.

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InCarda Therapeutics raises $42m for inhaled atrial fibrillation drug

InCarda Therapeutics logoInCarda Therapeutics said today that it raised $42 million in an oversubscribed Series B financing round led by Sofinnova and HealthCap.

Proceeds from the round are slated to support a Phase II trial of the company’s inhaled paroxysmal atrial fibrillation drug, InRhythm.

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

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Visioneering Tech touts NaturalVue contact lens pediatric myopia study

Visioneering Technologies

Visioneering Technologies Inc yesterday released results from a pediatric study of its NaturalView multifocal contact lens intended to treat myopia, touting

Results from the trial were presented by study lead Dr. Thomas Aller of the UC Berkeley School of Optometry at the American Academy of Optometry Conference in San Antonio this week.

In the trial, investigators examined changes in vision and eye shape in myopic children wearing the NaturalVue multifocal contacts, with 24 children completing a six-month follow up and 19 completing 12 months. The average age in the study was 10.8 years old, the Atlanta-based company said.

Prior to wearing the NaturalVue lenses, children experienced worsening myopic vision by 1.28 ± 0.79 diopters per year, Visioneering Tech said. For the year the children wore  the NaturalVue multifocal lens, the rate was reduced to 0.24 diopters per year, a decrease of 1.04 diopters per year, or an 81% reduction in the rate of progression.

Data from the trial also indicated that the lenses reduced changes in eye shape in the patients, reducing from an average predicted increase in axial length of 0.43 ± 0.26 mm in the year prior to wearing the lenses to 0.20 ± 0.19 mm in the year while wearing them, Visioneering Tech said.

“The prevalence of myopia is increasing among children globally at alarming rates, and identifying better ways to manage myopia has become a top priority for vision care experts worldwide. The NaturalVue Multifocal data are very encouraging based on the level of decrease in changes in both refractive error and expected axial length growth, especially in a group of very fast progressing myopic children. To achieve more than 1.00 diopters of decrease in myopic refractive error change on a prospective basis after one year is quite remarkable and promising. The unique design of NaturalVue Multifocal offers intervention for multiple potential causes of myopic progression, and its availability as a daily disposable contact lens makes it ideal for use in children. I am excited to continue this research and follow these children into their second year of wear,” Dr. Aller  said in a press release.

Last March, Visioneering Tech said that it closed a $25.5 million (AUD $33.3 million) initial public offering in Australia, with funds going to support its NaturalVue multifocal contact lenses.

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FDA approves Medtronic renal denervation trial in on-med patients

Medtronic logo updatedMedtronic (NYSE:MDT) said today that the FDA approved a clinical trial of its Symplicity Spyral renal denervation device in patients who already take medication for their high blood pressure.

Fridley, Minn.-based Medtronic said the three-year, 340-patient Spyral HTN-On Med sham-controlled study is designed to compare treatment with the Symplicity Spyral device and a sham procedure, randomized on a 2:1 basis, after treatment with up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors and beta blockers. The primary safety endpoints include major adverse events at one month and new renal artery stenosis at six months. The primary efficacy endpoint is 24-hour ambulatory blood pressure at six months.

The pivotal trial is based on a pilot investigational device exemption study that showed an average 9mm Hg drop in 24-hour mean systolic ambulatory blood pressure in the treatment arm at six months.

“Medtronic is committed to building a robust global renal denervation clinical program with results from several randomized, sham-controlled, prospectively-powered, blinded clinical studies, in both the absence and presence of prescribed medications,” coronary & renal denervation GM Dave Moeller said in prepared remarks. “Results from the On Med trial will add to the growing body of evidence supporting renal denervation and is intended to support clinicians in making treatment decisions for patients who might benefit from this procedure.”

“A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches,” added principal investigator Dr. David Kandzari of Atlanta’s Piedmont Heart Institute. “This trial will add yet another critical piece to the RDN evidence basis and is designed to build on the success of our pilot study, which showed a benefit for RDN in an on-med patient population.”

Looking to clear up some confounding factors

Back in January 2014, Medtronic shocked medtech when it announced the failure of a highly anticipated trial examining ablation of the nerves around the renal arteries in treating hypertension.

The company suspended enrollment in other Symplicity studies and later took a $200 million write-down on its renal denervation assets. News of the trial’s failure reverberated throughout the medical device industry, prompting other companies to follow suit by either scaling back their RDN programs or spiking them altogether.

But the Symplicity HTN-3 study’s failure was due to some confounding factors – namely, issues around differing medication regimens and patient compliance. Hence the design of the Spyral HTN program, involving both on- and off-medication trials.

Last summer Medtronic said positive preliminary results from one of those studies, the 353-patient Spyral HTN-Off Med IDE study, prompted it to proceed with its plans to win regulatory approvals for the Symplicity Spyral ablation catheter in the U.S., Japan and elsewhere.

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VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon

Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries.

All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no participants required re-intervention of either the target lesion or the target vessel.

The data also supported improvements in Rutherford classification, resting ankle brachial index and walking impairment after 12 months.

“The ongoing positive results from this study demonstrate that the SurVeil DCB has the potential to be a next-generation DCB with improved efficacy of drug transfer,” co-principal investigator Dr. Kenneth Rosenfield said in prepared remarks. “These 12-month data continue to support the functionality and safety of the device.”

“Our goal all along with the SurVeil DCB has been to advance the technology to improve drug transfer and distribution effect on the arterial wall offering the opportunity to use a lower drug dose,” president & CEO Gary Maharaj added. “We are pleased with the ongoing results from the EFS and look forward to the opportunity to continue to demonstrate the potential for this technology with outcomes from our pivotal Transcend clinical trial that is currently underway.”

Read the whole VIVA2018 Roundup on our sister site, Drug Delivery Business News

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