Atanse Readies 510(k)s For Targeted Delivery Of Therapeutics To The Brain

Article preview from "The Gray Sheet"- June 7, 2010

Neurological instrumentation developer Atanse will submit a 510(k) in August for its IMI intracerebral microinjection instrument to deliver cell therapies to the brain to treat Parkinson's and the neurological disorder multiple system atrophy.

Atanse Readies 510(k)s For Targeted Delivery Of Therapeutics To The Brain

Article preview from "The Gray Sheet"- June 7, 2010

Neurological instrumentation developer Atanse will submit a 510(k) in August for its IMI intracerebral microinjection instrument to deliver cell therapies to the brain to treat Parkinson's and the neurological disorder multiple system atrophy.

The Boston start-up also plans to submit a 510(k) in September for its CEDSYS convection enhanced delivery system for brain cancer chemotherapy, targeting glioblastoma multiforme.

Both devices are designed to offer more targeted treatment pathways than currently available systems for a variety of diseases and conditions such as traumatic brain injury and strokes. The firm plans to pursue expanded indications over time.

The IMI system will address a $250 million market opportunity, while CEDSYS represents a market of $140 million, according to company estimates.

Atanse is readying two years worth of preclinical animal data to support the initial 510(k) applications for IMI and CEDSYS. The firm "is at the inflection point where things are going to start changing very quickly," said Miles Cunningham, M.D., Ph.D., co-founder, inventor and principal investigator.

Cunningham, who is also director of the Laboratory for Neural Reconstruction at McLean Hospital in Boston, presented details on the company's development plan at a May 20 session of the Neurotech Investing and Partnering Conference in Boston.

Systems Aim To Boost Precision

While specifications for IMI system components can vary based on the indication, versions of the device can incorporate a 100 micron microcannula, a 0.5 mm guide cannula and a microdrive unit about the size of a cell phone.

Surgeons would first drill a small, 2 cm diameter hole in the skull, through which the IMI system is positioned using a sterotactic procedure. The microcannula is extended at a predetermined angle from the guide cannula to enable delivery of the therapeutic agent. The microcannula is then withdrawn back into the guide cannula, rotated and advanced again at a predetermined angle for another injection.

Since the IMI system is compatible with magnetic resonance imaging, MRI can be used during the procedure to guide positioning, the firm notes.

A single injection procedure can last about an hour, while more complex procedures can last up to three hours.

The CEDSYS device, meanwhile, is designed to improve on existing convection enhanced delivery technology. While current systems permeate a brain tumor and its surrounding tissue with large volumes of chemotherapeutic agents under high pressure with a 1mm to 3 mm cannula, this can lead to infection and much of the treatment agent escaping away from the target site, Cunningham said.

In contrast, CEDSYS uses much smaller cannulas that are 200 to 800 microns in diameter, allowing them to be placed in greater numbers within the target tissue. The resulting treatment infusion offers reduced reflux, improved targeting and decreased patient morbidity, according to Cunningham.

Both the IMI and CEDSYS systems incorporate reusable and disposable components, and the complete systems would cost about $135,000 and $70,000, respectively. The cost of the procedures likely would be covered by reimbursement pathways already established for similar procedures, running about $20,000 to 35,000 each, according to the company.

Firm Seeks $1.5 Million Investment

Atanse has relied on SBIR grants for development work to date, including a $140,000 Phase I research grant in 2001, $750,000 for Phase II research from 2003 through 2005, and $800,000 for Phase IIB research in 2009-2010.

During the recent Neurotech meeting, Cunningham noted that Atanse is seeking $1.5 million in angel investment funding to help it complete the FDA regulatory process, as well as for patent, hiring and manufacturing logistics.

Cunningham and acting CEO Mike Kelly, a Boston-area entrepreneur, said they hope to partner with larger device or drug firms to facilitate distribution. The longer-term goal for Atanse is to be acquired, Kelly said.

- Mark Hollmer


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