Spotlight on New Medtech Firms at the 12th BIO Investor Forum Meeting in SF

— Palace Hotel, 12th Annual BIO Investor Forum meeting in San Francisco Oct 8-9, 2013.  According to David Thorcirus, the host of the opening meeting, this year’s BIO Investor Forum had about 700 attendees, 900 one-on-one partnering meetings and had a 30% increase in attendees compared to last year. The meeting focus is about small companies seeking funding or commercial partners. Of the 120 presenting companies, about 2/3 were private and about 1/3 were public stock firms.

Small Company Presentations Of Note.

  I found four new interesting medtech firms that were worth a first look.

1. Nano3D Biosciences (n3D) is new company run by Glonco Souza, the President and CSO.  The company is a spin-off of Rice University and the MD Anderson Cancer Center in Texas.  n3D’s mission is to develop the “Bio-Assembler” technology. They said it is a big paradigm shift in the developing of complex 3D tissue models.  They do this by levitating cells in dish. The Bio-Assembler (TM) is a nnao shuttle refill.  The product is covered by patent IP.

They get in-vivo -like results.  They claim to have the fastest 3D cell-based assay. It can produce results overnight vs. in 10 days. n3D uses Apple iPod Touch 4G mobile devices as computer controllers.

The “Magnetic Levitation Grows Realistic Lung Tissue…” in a headline in Science Magazine. The company uses ten Apple iPod Touch mobile devices for its compute platform.  Souza said that the limitation of existing 3D tools and assays for a small company. So far, n3D has raised $2.3 million.  Souza said that the investor exit strategy is to sell itself to a large company.  The firm is looking for customers, partners and investors.  Souza said that they currently need $600,000 in new funding.

2.Another new company, Nanofiber Solutions creates poly-nanofiber structures.  Ross Kayula, CEO, said that they place cells in fiber and look normal (cancer cells).  Their plates replace 2D plates. Their idea is similar to those of Nano 3D Biosciences.

The CEO said that their scaffold for implants prevents rejection and scarring in a trachea.  Their idea is a platform technology for organ regeneration — as implantable products.  Product status: Trachea in clinical trials; Other products are in pre-clinicals.

Ross said that IP is their largest cost and said that they need to raise a VC-backed seed-funding round of about $2 million.

3. iNanoBio is a new firm based in Tempe, Az. The company develops nanoscale sensors for combining nanoscale and diagnostics.  iNnaoBio seeks $7.5 million in a VC funding series.  The company is developing ultrafast next generation sequencing technology over the past nine months. The initial phase of their development is to make kinase activity high throughput screening. The CEO said that their technology is ultra fast an will sequence DNA in just fifteen minutes for about $200. They expect to target clinical applications using nanopore diagnostic technology. iNanoBio will make nanowire sensors attached to a nanopore to detect DNA in one pass at high speed. The firm is involved in an NIH program to develop their platform technology. The technology provides real-time detection of kinase proteins when compared to competing technologies from Thermo, Life Technologies, DiscoverX or others. The CEO said that their next step is to integrate microfluidics.  The manufacturing process is the same as in making semiconductor chips on a six-inch wafer. They can make a 1×3-inch slide with 10,000 wells to make an alpha-p53 assay. Their future n-MEDD product lines include: 1. Kinase chip assays, 2. Inhibitor discovery assay, 3. Target-ID assays for phenotypic screens. A key value is the real time kinetic results.  They are talking with Big Phama companies about their technology. iNanoBio plans to seek series A and B funding from VC firms.  The n-MEDD system development beta product is being shipped to customers.  They are developing a prototype genome sequencing device.

4. Metactive Medical is a medical device company run by CEO, Nicholas Franano MD.  He is the former founder of Proteon Therapeutics. The firm is developing two vascular repair products. Nicholas said that their first product involves a device for treating cereberal aneurisms that have a narrow neck. He said that cereberal aneurisms impact about 4% of the population. A rupture of an aneurism produces a hemorragic stroke which is often fatal. Patients usually have very bad headache symptom prior to an aneurism occurring. If they can detect the aneurism in time, the Dr. uses a catheter to put a coil of wire into the ball of the aneurism. The wire coiling procedure is the standard of care for treating cerebral aneurisms. This is a $500 million market segment. Dr. Franano said that wire coiling procedure is delicate, difficult and takes about two hours to complete.  He said that doctors need about two years training to perform this procedure. Unfortunately, about 3-5% of the aneurisms are punctured by dosctors. Each coil costs about $1,000 and some aneurisms require up to twenty wire coils.

Metactive Medical is developing a better device, the Ball Stent which is attached to a microcatheter. The Ball Stent is guided up to and into the ball of the aneurism. When activated, the end of the stent expands and fills the ball of the aneurism. A wire seals off the bloodflow from the artery at the neck of the aneurism. The procedure takes about twenty minutes. The company tested the idea in a pilot study in dogs by testing an 8mm Ball Stent. The successful procedure delivers a permanent treatment. The FDA classify would the Ball Stent as Class-2 Device and would require a 510K filing application. The second product is vacular device to repair peripheral artery occlusion.  This is a $50 to $75 million market. The Firm’s device deploys a ballon that repairs the artery wall. Dr. Franano estinmated that the market for the Ball Stent is $1 billion and the peripheral artery occlusion device market is $100 million.  He said that the company would sell itself for $200-250 million to a buyer or develop its products further. I asked when might the Ball Stent likely reach the market and Dr. Franano said that, if developed, it could reach Europe by 2020.

BIOInvestor Forum: Biotechs Fight Cancer Stem Cells

The CSC workshop was a hot topic at the BIOInvestor Forum at the Palace Hotel in San Francisco on October 9, 2012,.  At the “Cancer Stem Cell Therapy—Real or Just Hype?” workshop moderated by Nathan Sadeghi-Nejad, Contributor at Forbes & TheStreet, panelists talked about the difficulty of developing therapies for cancer stem cells (CSCs).

CSCs Can Evolve to Resist Chemo

John Lewicki, Executive Vice President and CSO, at OncoMed Pharma. Inc. said, “CSCs can resist attacks easily. They are fundamentally resistant to chemotherapy.  At OncoMed, we are trying to reduce that resistance with our antibodies by having multiple approaches.”  “Early on, we have seen data that is impressive with unique results.  We managed to control extremely aggressive ovarian cancer,” said Lewicki.

Tom Cirrito, VP of Research and Development, at Stemline Therapeutics, talked about the company’s SL-401 lead compound, for treating advanced acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Cirrito said, “We’ve treated 76 patients with a large body of preclinical evidence.”

Leslie Crews, Project Scientist, at Sanford Consortium for Regenerative Medicine/UC San Diego Cancer Center said, “We need to distinguish between tumor bulk and CSCs.  We also need a combination of strategies. These are evolving targets.  Cells evolve and evade therapies.  We should introduce CSC therapies later.”

Bernard Siegel JD, Talks Up Progress in Stem Cell Research

On May 18, 2011, I listened to a BIOtechNOW podcast about stem cell research.  BIOtechNOW’s Tracy Cooley interviewed Bernard Siegel, J.D., Founder and Executive Director of the non-profit Genetics Policy Institute based in Wellington, Florida.  She asked him about recent developments in stem cell research.  He said that it is “moving forward rapidly” and that in general, the field is not just focusing on basic fundamental research, but on also on translational medicine.  Siegel said there have been a large number of clinical trials with tissue specific stem cells and even a few with human embryonic stem cells (hESCs).

However, there are a lot of problems and challenges in the field that have to be overcome to really take the promise of stem cell research into reality and treatment and cures, he said.  According to Siegel, these include regulatory, reimbursement, and intellectual property issues. When asked what he thought about the realistic outlook for stem cell research in the next 5-10 years, he said that “we’re going to see tremendous progress.”  He is hoping that we will find a way to overcome the regulatory and political hurdles related to hESCs. Unfortunately, in the U.S. there is still a roiling debate over the use of these cells in fundamental research that isn’t going to be resolved anytime soon, he said.

Siegel also talked about the Sherley v. Sebelius case involving human embryonic stem cells (hESCs).  He said that case shocked the scientific community when, in August 2010, Judge Royce Lamberth of the U.S. District Court for the District of Columbia entered a preliminary injunction to halt federal funding of hESC research and so the matter was taken up on appeal.  On April 29, 2011 the U.S. court of appeals in Washington D.C. entered its ruling and that court vacated the preliminary injunction that had been entered by the trial judge.

According to Siegel, while this is a good thing for the deal, it has not brought the certitude that is needed in order to move the deal forward.  He said that researchers need certitude so that they can hire their post docs.  They need to know that when they begin an experiment there will be enough funding to carry it through to the end.  However, this court case puts all of this in jeopardy.  Siegel also added that this appellate decision has not resolved the case entirely and that there are two critical issues for which the trial judge can enter a judgment again in favor of the plaintiffs.

Siegel’s organization, Genetics Policy Institute, has filed an “amicus curiae” brief, which means a “friend of court brief,” presenting legal arguments in the case in support of the government’s position.  Not only do we see the battle reflected in a federal court case but right now there are many, many states that are considering anti hESC legislation, he said.  His overall optimism related to the field of stem cells and hESC research is tempered by the political debate.

The Genetics Policy Institute has built a coalition called the “Stem Cell Action Coalition,” that is comprised of 70 different organizations such as the American Academy of Urology, the Cell Transplant Society, and the Alpha One Organization.  The focus of the coalition is to bring about public awareness and to really show to the public, the accomplishments in the field of hESC research.  Siegel feels that the Stem Cell Action Coalition fills an unmet need in the debate and will help bring about the day when human stem cells can really reach their full potential.