AngelMD Portfolio Company Saranas Awarded FDA De Novo Designation

The ultimate goal of AngelMD is to facilitate improved outcomes for startups, investors, and ultimately for patients. Today we are proud to share the news that Saranas, an AngelMD portfolio company, has obtained FDA clearance for its Early Bird Bleed Monitoring system. 

A recent study of over 17,000 large-bore transcatheter interventions showed that nearly one in five patients experience a bleeding-related complication. Saranas’ novel early-detection system addresses an unmet need for real-time detection and monitoring of these problems. The company’s last funding raise, in which AngelMD was also a proud investor, allowed for Saranas to submit the De Novo application to the FDA and launch a multi center clinical pilot within the United States.

Saranas originated from the Texas Heart Institute at the Texas Medical Center. Its goal is to provide real-time monitoring without the need for radiation, and at a lower cost than the status quo. 

The Early Bird Bleed Monitoring System is now being piloted across multiple centers to assess its versatility, and to increase patient safety. The company plans to launch the system commercially in selected centers across the US.

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Check out Your New AngelMD Startup Dashboard

We’re always looking for ways to improve your AngelMD experience. Today we’re letting you know about some improvements that we’ve made to your Startup Dashboard.

It all starts with the design. We’ve given your Dashboard a makeover that focuses on making your life easier. You’ll now see a larger version of your logo on the left side of the page. If you want to edit your company information or your settings, you can do so by clicking on the three dots to the right of your logo. You can still access your settings from the top right, but we wanted to make it easier for you to keep your profile up to date.

The right side of your Dashboard now includes a snapshot of your visitors from week to week. Now you’re able to see the results of your work on AngelMD at a glance. Not getting the eyeballs that you want? Make sure you are posting status updates and sharing information through your profile.

Speaking of posting startup news, it’s now easier than ever. The new interface in the middle of your screen gives you quick access to share a message. If you make a mistake, don’t worry, this isn’t Twitter. You can easily edit a post by hovering over its top right corner and clicking the three dots to bring up the Edit or Delete options. Your new Activity Analytics will let you know, at a glance, who has been watching what you’re sharing.

If you’re curious about who will be seeing those updates, that’s now easier to track as well. You can now see all of your company’s connections across the AngelMD network. Investors, Advisors, and Followers are all available from the box on the right side of your Dashboard, with the option to quickly follow someone back if you so choose.

To finish out this round of updates, we’ve also given you a whole new set of controls for promoting and tracking your funding rounds. We know that raising money is time-consuming, so we wanted to make AngelMD the easiest way for you to meet your goals. You can add funding rounds, and then track them directly from the sidebar so you can the information you need when you need it.

We love getting your feedback, and we look forward to hearing what you think about these new Dashboard updates. Have something on your mind? Drop us an email and let us know.

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Introducing AngelMD’s Strategic Alliance with the Rapacke Law Group

AngelMD is proud to announce its strategic alliance with The Rapacke Law Group. This alliance will help AngelMD members navigate the legal side of healthcare startups without the expense required to keep a lawyer on retainer. The Rapacke Law Group offers award-winning, price predictable legal counsel to AngelMD startups, physicians, and investors.

At AngelMD, we’re always excited when we find companies that can help to remove some of the heavy lifting required by startups, physicians, and investors on the network. The Rapacke Law Firm is offering a special set of benefits specifically to AngelMD members that will not only help them handle legal issues, but will also save them money in doing so.

  • Free one-hour strategy session with an experienced attorney
  • 20% off all legal services
  • Free provisional patent application
  • Up to $15k line of credit for one-year toward legal services

Patent, trademark, IP protection, business formation and M&A are areas of focus that every company and investor will encounter at some point on their journey. However, neither startups nor investors have the legal expertise to make sure that their interests are well protected. This strategic alliance with the Rapacke Law Group can help to cover these needs, while also offering legal counsel in many other areas.

For more information, or to get started, visit the AngelMD Service Partners page, and click on the Rapacke Law Group link.

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AngelMD Portfolio Company Raydiant Oximetry Awarded FDA Breakthrough Device Status

In the United States, roughly one out of every three babies born in the United States are delivered via cesarean section. According to key stakeholders, nearly half of these c-section deliveries are medically unnecessary. These major surgeries carry risks such as postpartum hemorrhage, rupture of the uterus, cardiac arrest, infection, complications from anesthesia, and much more.

Raydiant Oximetry, Inc. is a California-based company that has developed a safe and noninvasive technology that directly monitors a baby’s oxygenation during pregnancy. For clinicians who are dissatisfied with the lack of tools available to assess the baby during childbirth, this technology will lead to improved decision making and better care to mother and baby. Today, the company is announcing that it has been awarded Breakthrough Device status by the Food and Drug Administration (FDA).

“The FDA’s approval for a Breakthrough Medical Device status is an incredible validation for the work that we are doing,” said Raydiant Oximetry CEO Dr. Neil P. Ray. “Not only does it accelerate the path towards FDA approval, it’s also a public health validation that what we have been developing is a global priority for the health of mothers and babies.”

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The FDA’s Breakthrough program is targeted towards medical devices that address significant unmet clinical needs. It provides an expedited pathway to approval for market access. This pathway affords the sponsor a priority review with senior personnel and less pre-market clinical data for expedited approval.

“It is baffling that the public outcry over our current c-section rate isn’t louder than it is,” said AngelMD Lead Investor Dr. Wendy Whittington. “Raydiant’s new breakthrough status confirms that safe, effective tools to give doctors better information about in utero well being are necessary and timely. Tools to enable doing the right thing are welcome and necessary in this pivotal time for our healthcare system.”

AngelMD announced in September 2018 that a group of its investors had completed a funding round in Raydiant Oximetry. The company is now working on building its next generation prototype, to improve accuracy and reliability, which is slated for completion in February of 2019.

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AngelMD Investor Group Completes Funding Round in Access Vascular

Today, AngelMD is announcing the close of a $594,000 round of funding for Access Vascular, Inc. The syndicate funding is part of the total $3.4 million round that has now been closed by the company.

A peripherally inserted central catheter (PICC) is a critical component to long-term intravenous treatments. However, the status quo for PICC equipment has an inherent problem — the potential for deep vein thrombosis and pulmonary embolism. These conditions can occur because blood platelets begin to deposit on the PICC’s surface immediately after placement. Based in Massachusetts, Access Vascular has developed the HydroPICC — a PICC developed with proprietary bulk hydrophobic material which is highly resistant to platelet deposit.

“We are grateful for the support that our new and existing investors have given us as we prepare for the roll-out of our first product,” said Access Vascular CEO James Biggins. “In addition to funding the initial post-market use of our FDA-cleared HydroPICC, the funds will support the development of other products in our pipeline. This includes a version of our device that may be capable of controlled release of drugs over an extended period of time to actively kill bacteria over the lifespan of the device.”

Access Vascular has recently passed a number of milestones on its route to market release. In September, the company released the results of its preclinical studies. These studies showed that in in-vitro and in-vivo use, Access Vascular’s HydroPICC achieved a 97 percent reduction in thrombus accumulation versus existing market options.

“I first became aware of the company through AngelMD. Access Vascular has met a huge need for vascular catheters that do not clot and cause complications for patients,” said Syndicate Lead Dr. Min Yoon. “CEO James Biggins discussed the technology in depth, and had a clear strategy to provide a return to shareholders.”

The company intends to begin a limited market release in October of 2018. This release will signal the first commercial use of the device.

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