Accurexa Submits its BranchPoint Device to FDA for 510(k) Clearance
SAN FRANCISCO, CA / ACCESSWIRE / June 15, 2015 / Accurexa Inc. (the "Company"
(OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it has filed a submission with the U.S. Food and Drug Administration (FDA) for 510(k) clearance to market its BranchPoint device.
The Company's BranchPoint device was invented to deliver therapeutics, such as stem cells, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration. The current standard of care is the use of straight, rigid needles, often requiring surgeons to penetrate the brain multiple times for the delivery of therapeutics, which in turn may increase the risk of bleeding, stroke and reflux of therapeutics back out to the brain surface. A study at UCSF* (University of California, San Francisco) demonstrated that the use of a straight needle was associated with reflux of at least 75% of the infusion while no reflux was found with the BranchPoint design. Subsequent studies demonstrated that the BranchPoint device can function with interventional MRI (iMRI) guidance, which may further improve the efficiency of delivery.
"We are excited that we reached this important milestone today. We believe that this accomplishment demonstrates that our team at Accurexa is capable of bringing medical innovations to a regulatory submission to the FDA," said George Yu, the Company's President & CEO.
"I want to thank my research team, UCSF and everybody who was involved in this endeavor over the last several years. I also want to thank the California Institute of Regenerative Medicine, which provided nearly $2 million in support for the development of the BranchPoint device. If approved by the FDA, it would enable us to leverage this significant research investment for the clinical treatment of a wide range of diseases of the brain," said Daniel Lim, MD PhD, who is Associate Professor of Neurological Surgery at UCSF and the lead inventor of the BranchPoint technology.
Notes:
* Silvestrini MT, Yin D, Coppes VG, Mann P, Martin AJ, Larson PS, Starr PA, Gupta N, Panter SS, Desai TA, Lim DA. Radially branched deployment for more efficient cell transplantation at the scale of the human brain. Stereotact Funct Neurosurg. 2013;91(2):92-103.
** Silvestrini MT, Yin D, Martin AJ, Coppes VG, Mann P, Larson PS, Starr PA, Zeng X, Gupta N, Panter SS, Desai TA, Lim DA. Interventional magnetic resonance imaging-guided cell transplantation into the brain with radially branched deployment. Molecular Therapy. 2015;23(1):119-129.
About Accurexa, Inc.
The Company is focused on developing and commercializing novel neurological therapies based on its proprietary BranchPoint device delivering therapeutics directly into specific regions of the brain. The BranchPoint device can deliver therapeutics through the radial deployment of a flexible delivery catheter to large and anatomically complex brain targets through a single initial brain penetration. Clinicians can "tailor" therapeutic delivery to individual patient anatomy and specific disease targets, which may enhance the efficacy of therapies.
The Company is also developing its ACX-31 program which could deliver temozolomide, a chemotherapy drug, directly to brain cancer sites with its BranchPoint device. Temozolomide is a generic, approved, first-line chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar in 2012. However, current standard of care of delivering temozolomide to tumor sites through oral administration is limited by the blood-brain-barrier and orally administered temozolomide increases patient survival by a significant but modest 2.5 months from a 12.1 months median overall survival. Additional information about the Company may be found on its website, www.accurexa.com.
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company. All statements, other than statements of historical fact included herein are "forward-looking statements" including statements regarding: the ability of the Company to successfully file its 510(k) submission to the FDA, to successfully develop and commercialize novel neurological therapies based on its BranchPoint device and its ACX-31 program, and execute its business plan; the business strategy, plans, and objectives of the Company; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions and involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume any duty to update these forward-looking statements.
Contact Investor Relations:
Capital Group Communications
575 Bridgeway, Sausalito CA 94965
Mark Bernhard
Tel: 415-332-7200
mark@cgcone.com
Mark Gundy
Tel: 972-240-1873
markgundy@gmail.com
Accurexa Inc.
info@accurexa.com
Tel.: 415-494-7850
SOURCE: Accurexa, Inc.
SAN FRANCISCO, CA / ACCESSWIRE / June 15, 2015 / Accurexa Inc. (the "Company"
(OTCQB: ACXA), a biotechnology company focused on developing and commercializing novel neurological therapies, announced today that it has filed a submission with the U.S. Food and Drug Administration (FDA) for 510(k) clearance to market its BranchPoint device. The Company's BranchPoint device was invented to deliver therapeutics, such as stem cells, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration. The current standard of care is the use of straight, rigid needles, often requiring surgeons to penetrate the brain multiple times for the delivery of therapeutics, which in turn may increase the risk of bleeding, stroke and reflux of therapeutics back out to the brain surface. A study at UCSF* (University of California, San Francisco) demonstrated that the use of a straight needle was associated with reflux of at least 75% of the infusion while no reflux was found with the BranchPoint design. Subsequent studies demonstrated that the BranchPoint device can function with interventional MRI (iMRI) guidance, which may further improve the efficiency of delivery.
"We are excited that we reached this important milestone today. We believe that this accomplishment demonstrates that our team at Accurexa is capable of bringing medical innovations to a regulatory submission to the FDA," said George Yu, the Company's President & CEO.
"I want to thank my research team, UCSF and everybody who was involved in this endeavor over the last several years. I also want to thank the California Institute of Regenerative Medicine, which provided nearly $2 million in support for the development of the BranchPoint device. If approved by the FDA, it would enable us to leverage this significant research investment for the clinical treatment of a wide range of diseases of the brain," said Daniel Lim, MD PhD, who is Associate Professor of Neurological Surgery at UCSF and the lead inventor of the BranchPoint technology.
Notes:
* Silvestrini MT, Yin D, Coppes VG, Mann P, Martin AJ, Larson PS, Starr PA, Gupta N, Panter SS, Desai TA, Lim DA. Radially branched deployment for more efficient cell transplantation at the scale of the human brain. Stereotact Funct Neurosurg. 2013;91(2):92-103.
** Silvestrini MT, Yin D, Martin AJ, Coppes VG, Mann P, Larson PS, Starr PA, Zeng X, Gupta N, Panter SS, Desai TA, Lim DA. Interventional magnetic resonance imaging-guided cell transplantation into the brain with radially branched deployment. Molecular Therapy. 2015;23(1):119-129.
About Accurexa, Inc.
The Company is focused on developing and commercializing novel neurological therapies based on its proprietary BranchPoint device delivering therapeutics directly into specific regions of the brain. The BranchPoint device can deliver therapeutics through the radial deployment of a flexible delivery catheter to large and anatomically complex brain targets through a single initial brain penetration. Clinicians can "tailor" therapeutic delivery to individual patient anatomy and specific disease targets, which may enhance the efficacy of therapies.
The Company is also developing its ACX-31 program which could deliver temozolomide, a chemotherapy drug, directly to brain cancer sites with its BranchPoint device. Temozolomide is a generic, approved, first-line chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar in 2012. However, current standard of care of delivering temozolomide to tumor sites through oral administration is limited by the blood-brain-barrier and orally administered temozolomide increases patient survival by a significant but modest 2.5 months from a 12.1 months median overall survival. Additional information about the Company may be found on its website, www.accurexa.com.
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company. All statements, other than statements of historical fact included herein are "forward-looking statements" including statements regarding: the ability of the Company to successfully file its 510(k) submission to the FDA, to successfully develop and commercialize novel neurological therapies based on its BranchPoint device and its ACX-31 program, and execute its business plan; the business strategy, plans, and objectives of the Company; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions and involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume any duty to update these forward-looking statements.
Contact Investor Relations:
Capital Group Communications
575 Bridgeway, Sausalito CA 94965
Mark Bernhard
Tel: 415-332-7200
mark@cgcone.com
Mark Gundy
Tel: 972-240-1873
markgundy@gmail.com
Accurexa Inc.
info@accurexa.com
Tel.: 415-494-7850
SOURCE: Accurexa, Inc.
