Royalty Report: Medical, Cancer, Therapeutic – Collection: 250127

License Grant

The Company entered into an exclusive world-wide Start-up License Agreement with the University under certain patents licensed by the University and a non-exclusive world-wide license for certain know-how for the development and commercialization of a new form of High Intensity Focused Ultrasound called ‘Boiling Histotripsy’.  We also have the right to grant sublicenses for the licensed technology.

License Property

Boiling Histotripsy is a new form of High Intensity Focused Ultrasound.

HIFU is a non-invasive therapy that uses focused ultrasound waves to thermally ablate a portion of tissue, meaning the tissue is destroyed using intense heat. The intense heat causes tissue coagulation necrosis, cavitation and heat shock in the cells, meaning that the portion of tissue which is being ablated is destroyed. High power ultrasound can be focused on a targeted point to raise the temperature to 70-80°C. HIFU uses sonication (sound energy) to create this heat. Each sonication heats only a small focal target, so the interventional radiologist will use multiple sonications to ablate the whole affected area. The interventional radiologist may use diagnostic sonography with focused ultrasound (USgFUS or USgHIFU) or magnetic resonance guidance with focused ultrasound (MRgFUS). HIFU is used to treat fibroids, prostate cancer, kidney cancer and primary and secondary liver cancer.

Histotripsy is the capability of therapeutic ultrasound to generate purely mechanical damage of tissue without thermal coagulation. Boiling Histotripsy occurs when the frequency is higher (one – 3 MHz), the pulses are much longer (3000 – 10000 cycles) and delivered less often (0.5 – 1 Hz). The peak pressures are lower, about p-=10-15 MPa and p+>40MPa. In this regime, boiling is initiated within each millisecond – long pulse due to effective tissue heating by shocks.

Licensed Rights
UW Reference #
Application Serial #
Filing Date
Type
Status

45293.01US1
61/384,108
9/17/2010
US provisional
Converted

45293.02US2
8,668,658
9/19/2011
US non-provisional
Issued

45053.01US1
61/323,230
4/12/2010
US provisional
Converted

45053.02US2
8,876,740
4/12/2011
US non-provisional
Issued

45053.03US3
9,700,742
10/16/2014
US non-provisional
Issued

45469.01US1
61/646,489
5/14/2012
US provisional
Converted

45469.02US2
9,588,491
5/14/2013
US non-provisional
Issued

45567.01US1
61/474,080
4/11/2011
US provisional
Converted

45567.02US1
61/488,552
5/20/2011
US provisional
Converted

45567.03US2
9,498,651
4/11/2012
US non-provisional
Issued

46507.01US1
61/993,604
5/15/2014
US provisional
Converted

46507.02WO2
PCT/US2015/031189
5/15/2015
PCT application
Nationalized

46507.03US2
15/309,394
11/7/2016
US non-provisional
Allowed

46733.01US1
61/972,035
3/28/2014
US provisional
Converted

46733.02WO2
PCT/US2015/023069
3/27/2015
PCT application
Nationalized

46733.03US2
15/120,300
8/19/2016
US non-provisional
Pending

Field of Use

“Field of Use” means boiling histotripsy treatment of the prostate.

The Company intend to conduct a three-year preclinical trial in which we will attempt to demonstrate a functional and acoustically characterized preclinical US-guided transrectal BH therapeutic device for ablation of prostate tissue.

License Grant

Licensor hereby grants to Licensee an exclusive perpetual, worldwide license in, to and under the Licensor IP, with the right to grant sublicenses thereunder, to make, have made, import, export, use, offer to sell, sell, and/or otherwise dispose of HIFU Systems for use in the Licensee's Field and to utilize the Licensor IP in connection with the marketing, advertising, and promotion of HIFU Systems for use in the Licensee Field.

License Property

Licensor owns and otherwise possesses know-how and intellectual property necessary or useful for the manufacture and commercialization of systems for the delivery of high intensity focused ultrasound (HIFU) to the human body.

1 U.S. 60/471669 05/19/2003 Larry L. Smith Geometrically Shaped Coupling Hydrogel Standoffs for HIFU U.S. 10/847,232 05/17/2004 Larry L. Smith Geometrically Shaped Coupling Hydrogel Standoffs for HIFU Europe 04252734.1 05/12/2004 Same Same
2 U.S. 60/604,784 08/26/2004 Joseph Leonetti Larry L. Smith Geometrically Shaped Coupling Hydrogel Standoffs for HIFU (Acrylates)
3 U.S. 60/517,555 11/05/2003 Anthony Lowman Hydrogel Compositions and Manufacturing Process for Ultrasound Couplants U.S. 10/978,767 11/01/2004
4 U.S. 60/524,200 11/21/2003 Eugene Larson Perry Kaminski Yu-Chi Chu Bone Cancer Pain Management Utilizing Ultrasound U.S. 10/994,421 11/22/2004 Same
5 U.S. Perry Kaminski Eugene Larson Hand-Held HIFU 6 U.S. Perry Kaminski Yu-Chi Chu Automatic Thermal Dose Regulation 7 U.S. Disclosure Perry Kaminski Device for extracting heat from HIFU transducers 8 U.S. Disclosure Perry Kaminski Nonlinear Focusing Device for HIFU transducers.

Field of Use

Licensee Field shall include the following (a) cardiac cauterization by the application of ultrasound to cardiac tissue to create a lesion, scar or partial necrosis in order to ablate, block or delay electrical conduction in such tissue; (b) making connecting lesions between anatomical structures including connecting lesions to the mitral valve; and (c) reducing the size of cardiac structures; provided, however, that the Licensee Field shall be deemed not to include (i) the treatment of cardiac disease from the esophagus, (ii) any treatment or diagnosis accomplished by placing the treatment device (i.e., transducer) on the surface of the body, or (iii) the treatment of cardiac valve leaflets, or their supporting structures, with HIFU.

License Grant

This agreement is to compromise, resolve and settle all asserted and unasserted claims relating to the allegations, and license technology.

Licensor grants an irrevocable, non-exclusive, worldwide right and license under the Licensed Patents only within the Technology Field to undertake Product Related Activities for Licensed Products and develop, make, have made, market, use, authorize others to use, import, distribute, sell, have sold and offer to sell Licensed Products, for the life of the Licensed Patents.

License Property

The patents are for Urethral inserted applicator for prostate hyperthermia and therapeutic prostatic thermotherapy.

Licensed Products shall mean Licensees Current Products and Reasonable Modifications thereof developed, manufactured, used, marketed, offered for sale, sold, imported, licensed or distributed by or on behalf of a Licensee Party or a permitted successor or assign under this Agreement, directly or through their respective manufacturers, distributors, contractors, resellers, and other intermediaries.

Current Products of a Party shall mean products and components thereof commercially available from that Party or its Affiliates at or before the Effective Date in the Technology Field, which for Licensee is the Prolieve Thermodilation System and for Licensor is the TherMatrx System.

Prolieve Thermodilation System offers a unique “Thermodilatation” treatment for symptoms of enlarged prostate, also known as benign prostatic hyperplasia (BPH). Prolieve® is a combination therapy simultaneously using Focused Microwave Heating together with Pressurized Balloon Dilatation therapy.

Field of Use

Licensee is, in part, in the business of developing, making, marketing and selling products, therapies and technologies that use heat generated by microwave energy to treat benign prostatic hyperplasia, including a product currently sold under the brand Prolieve Thermodilation System®.

Technology Field shall mean the field of microwave therapy for treating benign prostatic hyperplasia (BPH) and prostatitis.