Memphis Startup Restore Medical Becomes First To 510 (K) Out Of Zero To 510 Accelerator

Restore Medical Solutions, Memphis startup, 510KThe ZeroTo510 startup accelerator in Memphis Tennessee is the first cohort-based medical device startup accelerator in the country. The joint venture between Start Co and Memphis Bioworks puts medical device companies through an accelerator program and helps shape scientists and engineers into startup founders.

The other, important goal for ZeroTo510 is getting these medical device startups to the 510(k) approval from the FDA. This approval is a quicker path to market roughly based on the idea that your product is expanding on an idea or improving an idea previously approved by the FDA. In short a typical FDA approval for a new device can take anywhere from 3-10 years while a 510 (k) approval can shorten that time down to 1-3 years.

All of the companies selected for the first two completed cohorts at ZeroTo510 (summer 2012 and summer 2013) werelooking to get that approval and get their product to market.

Marston-1We’ve covered Restore Medical almost from the point when founders Shawn Flynn and Ryan Ramkhelawan made the move from Atlanta to Memphis for the accelerator at the beginning of summer 2012. At that time both founders told Nibletz that they liked Bioworks and the cohesiveness of the Memphis startup community, despite the fact that Atlanta is a much larger city.

Restore Medical has developed a system that more thoroughly, cleanly, cheaply and greenly sterilizes surgical instruments. The way surgical instruments are currently sterilized is time consuming. Not only that, but if one instrument is found to be unsterile the entire batch of instruments for a particular surgery needs to go through the process again. This can take hours at a time, so the OR teams must make a decision on whether to wake up the patient or to keep the patient under anesthesia which can be costly for the doctors and the patients not to mention dangerous.

“Our product allows hospitals to clean and re-sterilize surgical instruments more efficiently, saving time and money,”  Flynn, the company President said in a statement. “More importantly, it improves the sterilization process, reducing the chances that a patient will be infected by contaminated instruments.

Restore Medical Solutions announced on Thursday that they had received their FDA 510(k) clearance. The company is also pleased to announced that it has successfully completed the certification process for internationally recognized medical device specific quality management standards ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS). Certification was conducted by BSI Group, one of the world′s leading certification bodies.

“These clearances allow us to market our products domestically and internationally, and they show that our product is safe, effective and meets regulatory requirements in both the United States and Canada,” said Ramkhelawan.

Restore Medical Solutions is moving into a larger 2500 square foot space  in the Memphis Bioworks complex which will allow them space for assembly and distribution.

You can find out more about Restore Medical Solutions here.

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Memphis’ ZeroTo510 Accelerator Opens Applications For 2013

Restore Medical Solutions, Urova, Bioworks, ZeroTo510,Seed Hatchery, Allan Daisley

Shawn Flynn, co-founder of Restore Medical Solutions, pitches at ZeroTo510 investor day, a pitch that led to $2.5 Million dollars in follow on funding (photo: NMI)

Last year, the inaugural Zeroto510 medical device accelerator was met with phenomenal success. Five out of the six participating teams received follow on funding. Four of the teams received $100,000 dollars. The fifth team, Restore Medical Solutions, went straight to raising a Series A round at $2.5 million.

With results like those, medical device startups across the country are feverishly preparing to submit their applications for the next cohort. One of the secrets to the success of the Zeroto510 program is that it is a joint venture between Launch Your City’s Seed Hatchery accelerator and Memphis Bioworks. Bioworks supplies the lab space, and the deep rooted scientific and engineering mentorship. Launch Your City comes in with the curriculum to prepare the startups for pitching and success on the business side of the world.

When compared to other medical based accelerator and incubation programs, Zeroto510, through their unique partnership, is able to get their startup founders to communicate and pitch at a level understandable to the traditional investor, media and public. In a medically based program, founders and entrepreneurs with scientific and engineering backgrounds tend to get the science, and not necessarily the business.

Bioworks is able to offer a bridge from the surrounding medical community including St. Jude’s, Methodist, Vanderbilt University, the University of Memphis and other high ranking leaders in science and medicine, to offer hands on mentorship to refine these great ideas.

Zeroto510 gets it’s name from the FDA’s 510(k) pre-market notification filing. In laymen’s terms this filing allows medical device companies, with similar technology to something that has gone through FDA approval, to fast track a process which can sometimes take 3-5 years.

Six companies will be selected for the 2013 program. Each company will receive $50,000 in initial seed capital and be part of an intensive, mentorship driven 12 week program of instruction and hands on activities to guide the entrepreneurs through the process.

One of the other factors that makes Zeroto510 successful is the cohort size. By having a smaller group, the same size as the tech accelerator Seed Hatchery, the teams get to know each other better and collaborate more meaningfully. Last years program only featured one Memphis based startup. The other five startups relocated to Memphis for the program and are still, growing their companies in Memphis.

“We received applications from across the United States, carefully selected our six
participants and were very pleased with the quality of their ideas, the spirit of comradery that developed, the levels of learning, and, in the end, with the final presentations that resulted in additional funding. We expect even higher quality in 2013.” said Allan Daisley, director of entrepreneurship and sustainability for Memphis Bioworks.

If you’ve got a medical device startup head over to apply here at zeroto510.com

 

Startup Communities: Celebrating Victories

Brad Feld, startup investor, co-founder of Techstars, co-founder of Foundry Group, Marathon Runner, and huge startup community evangelist offers lots of great advice in his recent book on startup communities. One of the things that he speaks about when talking about startup communities is celebrating a startup community victory.

Earlier this morning we reported that Memphis startup accelerator grad Restore Medical Solutions has raised a $2.5 million dollar series A round.

That’s a huge victory for not only Restore Medical Solutions but for the Memphis Startup Community.

Linkage:

Original story

Come to Memphis for the biggest startup conference in the US

Memphis Startup Restore Medical Raises $2.5 Million Seed Round

Restore Medical Solutions, Memphis startup, Zeroto510,funded startup

Shawn Flynn (L) Ryan Ramkhelawan (R) founders of Restore Medical Solutions

Memphis’ startup community has kicked it into high gear as of late. In 2012 Launch Your City, the organization behind the Seed Hatchery starutp accelerator, the Launch Pad free coworking space and Launch Memphis, the curriculum arm behind Memphis’ startup ecosystem, had a big year. They saw two cohorts go through their Seed Hatchery program this year. One group of web/tech entrepreneurs took their startups through Seed Hatchery. The other group went through a collaborative effort between Seed Hatchery and Memphis BioWorks called Zeroto510.

The Zeroto510 program is a medical device startup accelerator that relies on Bioworks for the medical part and Seed Hatchery for the startup, and business development portion of their training. After a rigorous accelerator program, and an intense demo day in May, the six startups in the program saw 85% follow on funding. Four of the graduating startup companies received $100,000 investments from MB Ventures and Innova. The fifth startup, Restore Medical Solutions, raised a $2.5 million dollar Series A round.

It’s no wonder that Restore Medical Solutions was able to close such a large round. Co-Founder Shawn Flynn announced that the company had a $3.75 million dollar purchase order, during his investor day pitch.

Restore Medical Solutions has come up with a concept and system to more efficiently sterilize surgical instruments. When we first met with Flynn and Co-Founder Ryan Ramkhelawan explained that not only was the current system for sterilizing surgical instruments filled with flaws, to a degree it’s also dangerous.

Currently surgical instruments are grouped in sets according to the surgery that the operating room is performing. The instruments are kept in a sterile container/tray until they are brought up to the surgical suite and used. However, if one piece of equipment is either missing, or shows signs of not being completely sterilized, the entire set is deemed unusable and another set is ordered up.

The problem with that is most hospitals don’t have a bunch of reserve sets for the operating rooms. The sterilization team has put together the sets based on that days surgeries. Waiting on instruments to be re-sterilized and recompiled can take hours. At that time the patient is either kept under anesthesia or they are woken up, either option can have risks.

Not only that but some hospitals still use sterilization procedures that are likened to the way silverware is washed in a restaurant, everything dumped on one big tray and run through a dishwasher type sterilization machine. The problem with that is the instruments at the bottom may not be as sterile as the instruments on the top. This is often the cause of hospital born infections.

Restore Medical Solutions system makes the process quicker, more efficient and completely sterile.

Flynn and Ramkhelawan get anxious and excited when talking about their process and the upside potential for hospitals. With the reduction in time, the more efficient sterilization and the cut down on infections, Restore Medical Solutions is in the business of sterilizing instruments, but more importantly to the bottom line, driving costs down. Quicker turn arounds in the sterilization process also mean quicker turn arounds in the operating rooms, and more surgeries.

How much money? We’re not talking a thousands here or a thousand there, we’re talking tens of millions of dollars per hospital.

The duo behind Restore Medical Solutions has already pitched a number of hospitals in Tennessee and along the east coast. To date they are proud to announce that they’ve at least secured a follow up meeting and in other cases, purchase orders.

While a $2.5 million dollar Series A round is great for the company and will allow them to start producing to fulfill their purchase orders, it wasn’t always easy. Both Ramkhelawan and Flynn quit their good paying day jobs in Atlanta to relocate to Memphis for the ZeroTo510 program. The program gave them a $50,000 seed round but waiting for that initial funding they were sneaker-strapping it like the rest of their cohort.

Both men left families back in Atlanta and Ramkhelawan and his wife had just had a new baby daughter. With kids, families, and houses in Atlanta these two middle aged entrepreneurs set out to live the ramen noodle eating, hipster lifestyle. They immediately went on the grind to make things happen.

And happen it did.

After finding out about the ZeroTo510 program from a friend of Flynn’s who has a marketing business in Memphis the two made the trip to Memphis to scope out the city and the program. They immediately fell in love with the town. They are sharing an apartment literally within feet from the new corporate headquarters for Restore Medical which officially opens Friday.

For what they’re doing, both entrepreneurs admit that the Memphis startup ecosystem is further along than things are in Atlanta. New initiatives have begun in Atlanta which will be great for the region but Memphis is already doing it. Also, Jackson Tennessee is doing it as well. Both entrepreneurs spend time in Jackson, helping to further that cities entrepreneurs along as well.

Flynn and Ramkelawan give a lot of credit to Launch Your City’s Eric Mathews and Bio Works’ Allan Daisley who were instrumental in the Zeroto510 programs inaugural class.

Linkage:

Check out Restore Medical here

Check out Zeroto510 here

Apply for Seed Hatchery’s next session here

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