Prospective Grant of Exclusive Patent License: Catheter-Based Myotomy Devices And Systems

Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.

Legal Status

Notice

Prospective Grant of Exclusive Patent License: Catheter-Based Myotomy Devices And Systems

A Notice by the National Institutes of Health on 04/14/2026

• 1.

1.
This document has a comment period that ends in 30 days.
(05/14/2026) View Comment Instructions

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Health and Human Services Department for review. All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at /documents/2026/04/14/2026-07147/prospective-grant-of-exclusive-patent-license-catheter-based-myotomy-devices-and-systems.

It appears that you have attempted to comment on this document before
so we've restored your progress.
Start over.
1.
2. Comment * What is your comment about? Upload File(s) Note: You can attach your comment as a file and/or attach supporting
documents to your comment. Attachment Requirements.

Email this will NOT be posted on regulations.gov

Opt to receive email confirmation of submission and tracking number? Tell us about yourself! I am... * An Individual An Organization Anonymous First Name * Last Name * City Region State Alabama Alaska American Samoa Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Guam Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virgin Islands Virginia Washington West Virginia Wisconsin Wyoming Zip Country Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Côte d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People's Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao Macedonia, the Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States of Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Phone Organization Type * Company Organization Federal State Local Tribal Regional Foreign U.S. House of Representatives U.S. Senate Organization Name * You are filing a document into an official docket. Any personal
information included in your comment text and/or uploaded
attachment(s) may be publicly viewable on the web. I read and understand the statement above.

2. Preview Comment Please review the Regulations.gov privacy notice and user notice.
3. Document Details Published Content - Document Details Agencies Department of Health and Human Services National Institutes of Health Document Citation 91 FR 19144 Document Number 2026-07147 Document Type Notice Pages 19144-19145 (2 pages) Publication Date 04/14/2026 Published Content - Document Details

• PDF Official Content
  • View printed version (PDF) Official Content
• Document Details Published Content - Document Details Agencies Department of Health and Human Services National Institutes of Health Document Citation 91 FR 19144 Document Number 2026-07147 Document Type Notice Pages 19144-19145 (2 pages) Publication Date 04/14/2026 Published Content - Document Details
• Document Dates Published Content - Document Dates Comments Close 05/14/2026 Dates Text Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development May 14, 2026 will be considered. Published Content - Document Dates

• Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
  headings within the legal text of Federal Register documents.
  This repetition of headings to form internal navigation links
  has no substantive legal effect.

  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • SUPPLEMENTARY INFORMATION: Enhanced Content - Table of Contents

• Public Comments Enhanced Content - Public Comments Comments are being accepted - View Comment Instructions.

Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data Additional information is not currently available for this document.

Enhanced Content - Regulations.gov Data

- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2026-07147 Email Email this document to a friend Enhanced Content - Sharing

• Print Enhanced Content - Print
  • Print this document Enhanced Content - Print
• Other Formats Enhanced Content - Other Formats This document is also available in the following formats:

JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.

Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2026-07147 as it appeared on Public Inspection on
04/13/2026 at 8:45 am.

It was viewed
14
times while on Public Inspection.

If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.

Public Inspection
Published Document: 2026-07147 (91 FR 19144) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings Document headings vary by document type but may contain
the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.

Department of Health and Human Services

National Institutes of Health

AGENCY:

National Institutes of Health.

ACTION:

Notice.

SUMMARY:

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Septune, Inc., located in San Juan, Puerto Rico, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

DATES:

Only written comments and/or applications for a license which are received by the NHLBI Office of Technology Transfer and Development May 14, 2026 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Michael Shmilovich, Esq., MS, CLP Acting Director, phone number 301-435-5019 or shmilovm@nih.gov.

SUPPLEMENTARY INFORMATION:

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective license to Septune, Inc.:

NIH Ref No.	Patent No. or application No.	Filing date	Title
E-194-2025-0-US-01	63/890,784	September 30, 2025	Electrosurgical Myotomy Catheter System.
E-166-2022-0-US-01	63/383,012	November 9, 2022	Myotomy Catheter System And Methods For A Myotomy Catheter System.
E-166-2022-0-PC-01	PCT/US2023/079114	November 8, 2023	Myotomy Catheter System And Methods For A Myotomy Catheter System.
E-166-2022-0-US-02	19/127,710	November 8, 2023	Myotomy Catheter System And Methods For A Myotomy Catheter System.
E-166-2022-0-EP-01	23821091.8	November 8, 2023	Myotomy Catheter System And Methods For A Myotomy Catheter System.

The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent license territory may be worldwide and in a field of use limited to catheter-based myocardial myotomy systems for the treatment of cardiovascular disease.

The invention described in E-194-2025 for which we currently have a provisional patent application covers a variable-depth electrosurgical myotomy catheter system configured to perform a longitudinal endomyocardial myotomy, also referred to as septal scoring along the midline endocardium (SESAME). The catheter system is configured to slice the “septal hump” causing symptomatic left ventricular outflow tract obstruction in hypertrophic cardiomyopathy (HCM), a common congenital heart disease in adults and children. The system may have further applications in creating space to allow non-surgical transcatheter mitral valve implantation (TMVR), which excludes more than half of TMVR candidates, and potentially reduces left ventricular stiffness causing heart failure with preserved ejection fraction (HFpEF), a widely prevalent disease.

The invention described in E-166-2022, for which we now have pending national stage applications in the US and Europe, pertains to a controlled-depth myotomy catheter system configured to perform a longitudinal endomyocardial myotomy (also referred to as septal scoring along the midline endocardium (SESAME)) precisely and reproducibly with less operator skill than previous SESAME procedures, less reliance on image guidance, and lowered procedure times. SESAME is conventionally accomplished by navigating a 0.014″ guidewire under x-ray fluoroscopy and ultrasound guidance via a retrograde transaortic guiding catheter through the interventricular septum. A straight rigid engagement guidewire engages the basal ( printed page 19145) septum either mechanically or electrosurgically to allow a 0.014″ microcatheter to enter the basal septum. The instant invention replaces the 0.014″ engagement guidewire is with a 0.014″ curved-tip guidewire navigated through the septal myocardium towards the apex until it exits the myocardium and reenters the left ventricular chamber. The trajectory may be confirmed by ultrasound. The intracameral guidewire tip is ensnared to allow positioning of an inner-curvature-denuded laceration surface resembling the “flying-V” used for other procedures such as laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON). The “flying-V-like” configuration includes insulating microcatheters on both free limbs of the lacerating guidewire. Once positioned, the laceration surface is electrified under traction to accomplish SESAME. Currently, SESAME also requires general anesthesia and advanced imaging including combinations of transthoracic, transesophageal, and intracardiac ultrasound, even within the left ventricular chamber, as well as biplane fluoroscopy. Ultrasound imaging windows across the chest wall, from the esophagus, and even within heart chambers are usually insufficient to give high confidence in the guidewire position along its whole trajectory. As explained previously, the uncertain depth of endomyocardial scoring via conventional SESAME may result in too shallow a laceration (resulting in therapeutic failure) or too deep a laceration (resulting in ventricular septal defect or free wall rupture). Conversely, the device disclosed in E-166-2022 addresses these issues by providing a controlled-depth laceration. The myotomy catheter system may be referred to as a transcatheter articulated heart incision instrument (TAHINI) catheter system. The TAHINI catheter system includes an incision catheter and an anchor stabilization and orientation catheter system configured to stabilize and properly orient the incision catheter. The anchor stabilization and orientation catheter system includes one or more anchors that are configured to be positioned in the heart to guide the incision catheter to perform SESAME. The anchor(s) may include mural anchors that enter or traverse the wall of the heart (e.g., the septum) and/or endocameral stabilizing hoops (that stabilize the catheter within a heart chamber, such as the left ventricle). The incision catheter may include an articulated cutting tool (e.g., a lacerator/blade that can be insulated from other metal components and electrified to perform electrosurgery) that, when deployed, is angled relative to the septal myocardium (e.g., tangential) such that traction-withdrawal along an anchored guidewire causes the cutting tool to embed deeply into the septal myocardium.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within thirty (30) days from the date of this published notice, the NHLBI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: April 9, 2026.

Michael Shmilovich,

Acting Director, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.

[FR Doc. 2026-07147 Filed 4-13-26; 8:45 am]

BILLING CODE 4140-01-P

Published Document: 2026-07147 (91 FR 19144)