Compassionate Use Policy

Nanoscope Therapeutics, Inc.
Expanded Access Policy

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. 

Nanoscope Therapeutics, Inc.  is focused on successfully advancing our investigational drugs through the regulatory process as we know this will provide access of our drugs to the most patients in the shortest timeframe. In addition, the safety and efficacy of our investigational drugs, as well as optimal techniques for delivery, have not been fully established. As such, Nanoscope Therapeutics does not normally offer Expanded Access to our investigational drugs but rather encourages patients to speak with their physicians about eligibility to enroll in any of our clinical trials that may positively impact the patient’s illness.

On an exceptional basis, however, we may consider requests from US-licensed physicians for their patients who have exhausted all viable alternative therapies. Requests for Expanded Access must come from the treating physician via email to: info@nanostherapeutics.com. We will seek to respond to such requests within 10 business days.

Nanoscope Therapeutics will consider the following factors for potential compassionate use:

  • The clinical situation of the patient including whether all approved therapy or clinical trial options have been exhausted
  • Whether the treating physician believes that the potential benefits of our investigational drug will outweigh any potential risks to the patient
  • The ability of the treating physician to adequately communicate to the patient the potential risks and benefits of the proposed use of our investigational drug so that the patient can provide informed consent and the willingness of all parties to sign a release 
  • The ability of the treating physician to deliver our investigational drug utilizing intravitreal injection that are being established in our clinical trials
  • The likelihood that regulatory authorities and institutional review boards (IRB’s) will review and approve expanded access for the patient in a timely basis
  • Our past experience with the site IRB and the commitment of the treating physician to obtain IRB approval and maintain an investigational new drug (IND) application
  • The available supply of an investigational drug
  • The impact of providing expanded access on resources devoted to our development programs 
  • Other factors we may deem appropriate

Nanoscope Therapeutics, Inc.  reserves the right to revise or discontinue this policy without notice.

Nanoscope Therapeutics, Inc.
1312 Brown Trail, Suite A
Bedford, TX 76022
(817) 857-1186
  • Dr. Samarendra Mohanty, PhD |  Co-Founder & President

    Samarendra Mohanty (Co-Founder/President) is an inventor & serial entrepreneur with 20+ years experience in Biomedical Sciences. He is Co-Founder of several Biotechs and Biomedical device /diagnostic companies (developed & commercialized $100K+ biomedical instruments.)

    Samar obtained M.Tech in Applied Optics from the Indian Institute of Technology-Delhi and a PhD in (Bio)Physics from the Indian Institute of Sciences-Bangalore.

    His extensive Biomedical Technologies experience includes serving as Professor/Senior Scientist at the University of Texas;  University of California, Irvine; Center for Adv. Tech (India); Int. Mol. Biotech (Germany); Univ. Pavia (Italy); NUS (Singapore); and University of St. Andrews (UK). He has authored over 200 international patents and publications in leading journals including Nature and Nature Photonics.

    He is the Principal Investigator for major grants from National Eye Institute including Audacious Goal Initiative and Bioengineering Research grants. He serves on the editorial board of journals and chairs international conference on optogenetics. He is winner of 2019 Healthcare Heroes award (Fort Worth Business Press), Retinal Organoid Challenge Award, Audacious Goal Initiative Award (NIH), Finalist of Tech Titan, and NIH-Director’s Innovator Award.