Investigator Initiated Study Request Procedure for Both Pre-Clinical and Clinical Studies

The Lionheart Health and Leonhardt Ventures Investigator Initiated Studies Committee and Data Safety Monitoring Board is charged with considering requests for pre-clinical and clinical study support. The committee may award funding or other types of support to institutions, medical foundations, and professional societies whose mission includes public health treatment, scientific research and/or medical education.

For clinical studies the investigator is responsible for obtaining IRB or FDA approval prior to Lionheart Health or Leonhardt Ventures providing product at discounted prices or free of charge for the study. For pre-clinical studies, the investigator is responsible for following relevant national animal ethics and Good Laboratory Practice guidelines. Both clinical and pre-clinical studies undergo an additional ethical review by our investigator initiated studies committee.

For new indication studies the investigator is responsible for obtaining regulatory approval through the appropriate national body. In the USA approval for investigator initiated IDE trials should be provided by the FDA and/or an IRB which may be institutional or and Independent IRB.

Candidate products potentially available for investigator initiated studies from Leonhardt Ventures or Lionheart Health, Inc. include…

Lionheart Health, Inc.

  • BodStim TM bioelectric stimulation suits.
  • OrthoStim TM devices and biologics for joint and bone health.
  • HairCell TM devices and biologics for hair regeneration
  • SkinStim TM devices and biologics for skin regeneration.
  • ErectiStim TM and FemStim TM devices and biologics for sexual health.
  • Stem Cell Bra TM devices and biologics for breast augmentation.
  • TestiStim TM devices and biologics for testosterone management.
  • Second Brain TM devices and biologics for gut microbiota health.

Leonhardt Ventures LLC

  • BladderCell TM and B-Alive TM devices and biologics for bladder health.
  • KidneyCell TM devices and biologics for kidney health.
  • LiverCell TM devices and biologics for liver health.
  • RegenaLung TM devices and biologics for lung health.
  • Vascustim TM devices and biologics for wound healing including diabetic ulcers.
  • ImplantStim TM for accelerated implant healing and integration.
  • BreatheStim TM devices for better breathing and sleep.
  • InStim TM devices and biologics for treating inflammation disorders.
  • BioLeonhardt devices and biologics for heart regeneration.
  • Valvublator devies and biologics for heart valve regeneration.
  • CancerCell TM devices and biologics for cancer treatment.

If an already FDA cleared device is being studied for any indication of use investigators may qualify for a 40% discount below standard prices. If a device or biologics is not FDA cleared but subject to Category B the company expects to be reimbursed cost of producing the device for the studies as the law permits. If a device or biologics to be studied does not qualify for Category B then the committee may authorize providing investigational devices free of charge.

To receive an investigators brochure, relevant forms and supporting data please write [email protected] with your request specifying the product you are interested to study and the proposed indication of use with information about the research experience of your team and institution.