ThermoFisher Aims to Get FDA OK for its Ion Torrent PGM

By Paula Myers

At this year’s CHI Molecular Medicine Tri-Conference at the Moscone Convention Center, San Francisco, February 11th, there were over 3000 attendees and more than 200 exhibitors. I visited some of the many booths on the exhibit floor. One of those was the ThermoFisher booth. I spoke with Zhen Mahoney,Sr. Clinical Sales Specialist/Pharma Business. Mahoney talked about the acquisition of Life Technology and how it affects ThermoFisher.  Thermo will have to absorb Life’s 9,000 employees. Thermo currently has 40,000 employees. Mahoney pointed out that Life has a broad product portfolio. Ion Torrent, which Life acquired in 2010, is located at Oyster Point near South San Francisco. The rest of company is located at Carlsbad, California, near San Diego, including the Invitrogen and Gibco brands. These groups are staying intact, according to Mahoney.

She also pointed out that the company submitted an application for 510K marketing clearance to the FDA for its Ion PGM system for use as a diagnostics medical device. They are hoping for a 3 to 4 month approval timeframe. By comparison, the Illumina MiSeq took about 9 months to get FDA 510K approval because it was the first of its kind. The Illumina MiSeq received a relatively fast approval because the company worked closely with FDA reviewers so that they can understand its technology. The MiSeq platform serves as a template to the FDA for follow-on platforms from Illumina and other desktop sequencer vendors. Mahoney said that the next revision for their Ion Torrent electronic P-2 Chip is coming later in 2014. It will have 660 million wells.

Some of the other firms that I visited included: Guardant Health, Diagenode, and Epitomics. I focused on companies involved in epigenetics. Guardant Health is a two-year-old service company for individuals. In February, they released GUARDANT360, the first pan-cancer blood test that provides doctors with real-time genetic information to help them prescribe the right treatments for their cancer patients.

  Diagenode is a company originally from Belgium and sells Japanese made disruptor shearing machines such as the Bioruptor Pico for DNA, chromatin, and RNA shearing. Epitomics, located in Burlingame, California, offers custom antibody services for use in epigenetics research. Li Fang, Project Manager of Custom Antibody Services at Epitomics, said that Abcam is buying the company. Abcam is a supplier of antibodies,proteins, kits and reagents.

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.

Smart Pill Helps Patients With Drug Compliance

San Jose Convention Center, December 6, 2011. During the luncheon at the conference part of the BIOMEDevice Expo and Conference, I met Patricia Johnson, Director for Pharma Integration, at Proteus Biomedical, Inc. , a medical device maker.  She explained to me about one of the company’s products.  She said that they have developed ingestible event markers (IEMs) that use the body to power the device.

IEM’s are tiny (the size of a grain of sand), digestible sensors made from food ingredients.  The IEM can be integrated into any drug tablet or capsule without changing its properties or performance.  After the pill is swallowed, the stomach fluids activate the pill.  The IEM creates a digital signal that is then detected by a microelectronic recorder, which can be configured as either a skin patch or a tiny device implanted under the skin.  The detector records the information that includes the type of drug, dose, and place of manufacture, etc.  It also measures and reports vitals such as heart rate, activity, and respiratory rate.  The information is sent up to the cloud where it can be retrieved and reviewed by the doctor.  Two of its partners include Novartis and Medtronic.

Drug non-compliance as well as making sure a drug regimen is working is a big problem with older or chronically ill patients.   This can reduce the number of doctor visits and relieve some of the stress felt by family caregivers.   It is especially helpful for patients that live alone and in remote areas.  Being a caregiver myself, I am excited about the potential of this product.

Using Nanofibers to Build Better Brain Tissue

I recently watched a video about nanofibers that was amazing.  Engineers and medical researchers at Nanofiber Solutions and the Ohio State University Comprehensive Cancer Center (OSUCCC) are using polymer nanofibers to simulate the three-dimensional structure of human tissue in plastic petri dishes.  These translucent spider-web like nanofibers are 100 times thinner than a human hair.

Normally, researchers would study live cancer cells under the microscope in petri dishes but it does not tell them how they interact in humans.  Since nanofibers are the exact size and spacing as human brain tissue, cancer cells behave more naturally on this than they would on plastic.  This gives scientists a more realistic environment to develop drugs that work.

This new approach could change how tumors are treated.  Doctors could someday take a biopsy of a tumor, put it in this tissue and try out different drugs on it all in the lab.  According to researcher Mariano Viapiano, PhD at OSUCCC, “the treatments that we are doing are specific for that biopsy for that patient.  So that will allow us to eventually to say this is the potentially best treatment for that particularly patient.”

J.P. Morgan’s Healthcare Conference 2011

SAN FRANCSICO – The J.P. Morgan 29th Annual Healthcare Conference was held at the Westin St. Francis this week (Jan. 10-13, 2011).  This four-day healthcare industry investor event hosted about 350 company presentations, an increase from 338  last year. Compared to last year’s 7,250 attendees, this year’s event brought in about 8,700 registered attendees.  This increase suggests that investors are more optimistic about healthcare companies in 2011.

I heard from some attendees that suggested that perhaps more than 30,000 healthcare and investment industry professionals gathered throughout San Francisco this week as a direct result of the J.P. Morgan event.

This year’s event continued its traditional approach of hosting  presentations of a broad mix of small-cap to large-cap healthcare companies from across multiple sectors.  In addition, the conference this year included presentations from 22 not- for-profit organizations and 17 healthcare companies from China.

The conference included an interesting luncheon talk on Monday from Nancy-Ann DeParle.  She is Counselor to the President and Director of the White House Office of Heath Reform.  Her talk provided an information update on the Affordable Care Act that was enacted in 2010.  She spoke to an audience of about 1,500-2,000.

While her talk covered familiar themes about healthcare policy that was made in 2010, such as how we can lower costs, how to lower waste, how to change the delivery system, the high cost of US healthcare and so on, she tended to zero in on the small business and individual healthcare insurance market and the impact on entrepreneurial companies.  She said that she sees a failed healthcare insurance market for small businesses and individuals.  She said that the reality of  “job lock” stifles innovation.  That is, people cannot move to new jobs or to startup new innovative companies without the fear of healthcare insurance loss.

She spoke about the ‘Patients Bill of Rights’ that include consumer protections; the CMS Innovation Center which would be helpful to entrepreneurs; and the small business tax credits among other comments.

DeParle pointed out that there is a lot of misinformation going around the new healthcare law.  She said that the Affordable Care Act does not set prices, it does not disturb the doctor-patient relationship and there is no government take-over of healthcare.  She brought attention to the new information website: HealthCare.gov.  DeParle said that the opportunity for healthcare businesses is that is that there will be millions of new customers for health insurance, drug, medical device and other healthcare companies.

BIOMEDevice Expo Brings Exhibitors to San Jose

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Healthcare Reform and Its Impact on the Medical Device Firms

I recently attended the The BIOMEDevice Exhibition and Forum held at the San Jose McEnery Convention Center so that I might learn more about the medical device industry.  During the opening luncheon I listened to an interesting keynote talk given by Robert Grant.  Mr. Grant is a the President of Bausch and Lomb’s Surgical Division. He previously worked at Allergan, the company known for Botox and various eye care products.  Robert gave out some interesting information about national healthcare spending, a key regulatory and legal case involving a medical device and his comments about the impact of the recent ‘Healthcare Reform’ law on the medical device industry.

Robert said that the annual US healthcare spend has reached about $2.5 trillion. That figure works out to about $8,000/year,  for each person living in the US.  The US spending figure exceeds healthcare spending in other industrialized nations. Compared to the US, the country with the next biggest healthcare spend is Sweden, with $5,000/yr per person.   Australia and the UK are about the same, at $3,400/yr. per person

According to Robert, the high costs in HC are driven mainly by aging and obesity (diabetes). He also asserted that another spending driver is by how we educate doctors in this country.  It takes 4 to 6 years longer in the US to train doctors than it does in other countries.  For example, in other countries, students go from high school straight into medical school. In contrast, the costs of malpractice in the US is going up every year. Other countries have limits on malpractice claims against doctors.  Furthermore, all payors, device manufacturers, and so on, are profit-centric organizations that are looking to get higher earnings per share.  None of tese economic drivers have been addressed in the recent healthcare reform law.

The FDA is the safety watch-dog and is really tightening down now on device manufacturers.  This situation is especially likely following  the outcome of the Riegal vs. Medtronic case. Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels’ claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit Court affirmed this case.

Medical device manufacturers go through the FDA, therefore the FDA is on the hook for the safety of medical devices.  The FDA is not motivated to get products to market.  As a result, they are not in a hurry to approve devices because of risk of products.

Robert summarized his observations and concerns with the following points:

  • Companies are having trouble raising money so they are leaving the country.
  • Aging and diabetes will break our healthcare system.
  • The High Cost of Malpractice Cases
  • The Doctors’ Education System Needs to Change
  • The FDA is not willing to take needed risk to get products on market sooner. Top people left the FDA since the Obama election.  Dan Schultz left FDA.  All that has led FDA to become more risk adverse.

He said that smart companies understand that the best opportunities often arise during the more difficult situations such as recessions or economic downturns. We’re going down such a time right now.  Republicans say ‘No’ to everything, but that’s not a good idea.

Robert said that its OK for companies to take reasonable business risks and make mistakes. People learn from mistakes, innovate, and improve their companies.  His company’s product is Crystalens, an intraocular lens.  Actress Florence Henderson is their spokesperson.  Their product is for cataract surgery. Cataract surgery patients can only get 20/40 vision from the procedure.   He said that their product is better than Lasik.  CMS has agreed to reimburse for their product.

For example, Robert said that when he was at Allergan, Cindy Crawford went up to him while he was attending an industry event and asked to be a spokesperson for their product Latesse, an eyelash grower. Robert was surprised that she knew about him and was very flattered.  He discovered that Baby Boomers want premium outcomes. Robert believes there’s a great opportunity in bad times.  Healthcare is at a precipice at this time.  It is unfortunate that medical device companies have to pay a new tax now under the new ‘Healthcare Reform’ law.

In closing his talk, Robert recited from memory the opening sentence from US Constitution, which listed several visionary points.  He talked about these points and also talked about President John Adams, one of the writers of the constitution.  He said that he viewed a TV show about him on HBO.  In 1776 John Adams described what should happen every July 2, but it actually turned out to be July 4th.  July 3rd he predicted future celebrations which continue to do every year.

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