Exhibit 10.18


 


Amendment No. 1 to

COLLABORATION AGREEMENT


 


between

Icahn School of Medicine at Mount Sinai

and Miromatrix


 


This Amendment No.1 (the "Amendment"),
effective as of April 27, 2016, is entered into by and between Icahn School of Medicine at Mount Sinai, a New York not-for-profit education
corporation, having a principal business address at One Gustave L. Levy Place, New York, NY 10029 ("Mount Sinai") and Miromatrix,
a Delaware corporation with a principal place of business at 10399 West 70th Street, Eden Prairie, MN 55344 ("Miromatrix").


 


WHEREAS, Mount Sinai and Miromatrix entered into
a Collaboration Agreement on October 19, 2015 (the "Agreement");


 


WHEREAS, the Parties intend to amend certain terms
of the Agreement, including the named Principal Investigator and the removal of native nephrectomies from the surgical procedure;


 


NOW THEREFORE, in consideration of the mutual
obligations in this Amendment and for other good consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties
to this Amendment hereby agree as follows:


 


		1.	Capitalized terms used but not defined herein shall have the respective meanings ascribed to such terms
in the Agreement.



 


		2.	The Principal Investigator set forth in the second WHEREAS clause of the Agreement is hereby amended to
be Dr. Sander S. Florman.



 


		3.	Exhibit A "Statement of Work" shall be deleted and hereby replaced in its entirety with the
attached Exhibit A "Statement of Work."



 


		4.	Except as specifically provided herein, the terms and provisions of the Agreement shall remain unchanged
and in full force and effect.



 


[SIGNATURE PAGE FOLLOWS]


 



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	AGREED AND ACCEPTED:	 
	 	 
	MIROMATRIX MEDICAL INC.	 
	 	 
	By:	 /s/ Robert Cohen	 
	 	 
	Name:	Robert Cohen	 
	 	 
	Title:	President & CEO	 
	 	 
	Date:	 5/18/16	 
	 	 
	AGREED AND ACCEPTED:	 
	 	 
	ICAHN SCHOOL OF MEDICINE AT
 MOUNT SINAI	 
	 	 
	By:	/s/ Sybil Lombillo	 
	 	 
	Name:	Sybil Lombillo, J.D., Ph.D.	 
	 	 
	Title:	 Director, Intellectual Property and
 Asset Development	 
	 	 
	Date:		 
	 	 
	READ AND ACKNOWLEDGED:	 
	 	 
	Principal Investigator	 
	 	 
	By:	/s/ Sander S. Florman	 
	 	 
	Name:	Sander S. Florman, M.D.	 
	 	 
	Title:		 
	 	 
	Date:		 



 




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EXHIBIT A


 


STATEMENT OF WORK


 


The initial development plan for our Transplantable
Kidney Program is divided into two Specific Aims consisting of work being performed both at Miromatrix and at Mount Sinai Hospital over
a 27 calendar month period to demonstrate and characterize the first steps involved in creating a transplantable kidney based upon Miromatrix'
perfusion decellularization/recellularization technology by demonstrating continuous blood flow through the transplanted kidney. Miromatrix
will perform all of the work related to Specific Aim #1, building upon our existing progress with our liver and cardiac patch programs,
to provide a re-endothelialized kidney for transplantation and evaluation. Mount Sinai will perform all of the transplantation and characterization
of the transplanted re-vascularized kidney for Specific Aim #2. Miromatrix will provide the re-endothelialized kidney grafts for each
transplant. Below is a summary of the planned actions and desired outcomes of the initial two year program.


 


Summary of Project Specific Aims/Milestones - 2 year program:


 


		A.	GMP Kidney Source, Characterization and Re-Endothelialization [9 months] - MIROMATRIX



		a.	Optimize kidney decellularization process from porcine sources



		i.	Aseptic decellularization of whole porcine kidney resulting in a controlled and repeatable process



ii. Define and characterize the appropriately
sized kidney


		b.	Characterize kidney matrix and identify key process



		i.	Advanced characterization of decellularized kidney including DNA, ECM integrity, vascular integrity, bioburden, and residual decellularization
detergent level



		c.	Define and implement GMP kidney decellularization process and quality system



		i.	Definition of release criteria to ensure high level quality control to support all continued development efforts



		d.	Complete kidney re-endothelialization with >80% re-endothelialization



		i.	Determination of the percent reseeding required (5% -75%) for functional revascularization



		ii.	Definition of non-invasive release criteria



 


		B.	Transplantation of the Re-Endothelialization Kidney and Demonstration of Continuous Blood Perfusion both Acutely (2 hrs., n=10)
and Chronically (10 days, n=10) in a Pig Model [18 months] — MOUNT SINAI



 






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		a.	Demonstrate continuous blood perfusion through the transplanted re-endothelialized kidney in a pig model for 2 hrs. (n=10)



		i.	Surgically transplant the re-endothelialized kidney provided by Miromatrix



		•	Create the appropriate surgical procedure for the transplantation



		ii.	Monitor and record blood inflow and outflow during the procedure



		iii.	Perform Doppler imaging during the transplantation



		iv.	Perform angiogram at the end of the study to characterize vascular patency



		v.	Fix and submit explanted kidney for pathology



		•	Perform standard H&E staining and immunohistochemical staining for endothelial cells



		b.	Demonstrate continuous blood perfusion in a pig model for 10 days. (n=10)



		i.	Perform a nephrectomy to create a suitable transplant location for the re-endothelialized kidney



		ii.	Surgically transplant the re-endothelialized kidney, characterize active perfusion at time of implant, then close and recover the
animal



		iii.	Perform Doppler imaging at day 1, 3, 5, 8 and 10



		iv.	Perform perfusion studies at time of explant to characterize inflow and outflow rates on the exposed kidney



		v.	Explant the kidney and perform angiogram at the end of the study to characterize vascular patency
	 	vi.	Fix and submit explanted kidney
for pathology



 


		•	Perform standard H&E staining and immunohistochemical staining for endothelial cells



 






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