<SEC-DOCUMENT>0001213900-22-019840.txt : 20250116
<SEC-HEADER>0001213900-22-019840.hdr.sgml : 20250116
<ACCEPTANCE-DATETIME>20220414162825
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001213900-22-019840
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20220414

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Polyrizon Ltd.
		CENTRAL INDEX KEY:			0001893645
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		12/6 BOROCHOV ST.
		CITY:			RAANANA
		STATE:			IL
		ZIP:			4343306
		BUSINESS PHONE:		972-54-7979668

	MAIL ADDRESS:	
		STREET 1:		12/6 BOROCHOV ST.
		CITY:			RAANANA
		STATE:			IL
		ZIP:			4343306
</SEC-HEADER>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">April<FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt"><SUP></SUP></FONT>
14, 2022</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">U.S. Securities and Exchange Commission</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">Division of Corporation Finance</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Office of Life Sciences<BR>
100 F Street, N.E.<BR>
Washington, D.C. 20549</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 1in; text-indent: 0in">Attention:</TD>
    <TD STYLE="text-indent: 0in">Abby Adams</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in">Celeste Murphy</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in">Kevin Vaughn</TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in">Li Xiao</TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
  <TR STYLE="vertical-align: top">
    <TD STYLE="width: 0.5in; text-indent: 0in"><B>Re:</B></TD>
    <TD STYLE="text-indent: 0in"><B>Polyrizon Ltd.</B></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in"><B>Draft Registration Statement on Form F-1</B></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in"><B>Submitted February 22, 2022</B></TD></TR>
  <TR STYLE="vertical-align: top">
    <TD STYLE="text-indent: 0in">&nbsp;</TD>
    <TD STYLE="text-indent: 0in"><B>CIK No. 0001893645</B></TD></TR>
  </TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-indent: -0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">Dear Ms. Adams:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">On behalf of Polyrizon Ltd.
(the &ldquo;Company&rdquo;), we are writing to submit the Company&rsquo;s responses to the comments of the staff (the &ldquo;Staff&rdquo;)
of the Division of Corporation Finance of the Securities and Exchange Commission (the &ldquo;Commission&rdquo;) dated March 10, 2022,
relating to the above referenced Draft Registration Statement on Form F-1 (CIK No. 0001893645) submitted by the Company on February 22,
2022 (the &ldquo;Draft Registration Statement&rdquo;).</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">Concurrent with the submission
of this letter, the Company is filing via EDGAR Amendment No. 2 to the Draft Registration Statement (&ldquo;Amendment No. 2&rdquo;), which
reflects the Company&rsquo;s responses to the comments received by the Staff and certain updated information. For your convenience, the
Company is also delivering via email a copy of this letter and Amendment No. 2 marked to indicate changes from the Draft Registration
Statement.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">For ease of review, we have
set forth below each of the numbered comments of your letter and the Company&rsquo;s responses thereto. Capitalized terms used herein
but not defined herein have the meanings given to such terms in Amendment No. 2.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">&nbsp;</P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0; margin-bottom: 0pt; text-align: left">Tomer Izraeli<BR>
Polyrizon Ltd.<BR>
April 14, 2022<BR>
Page 2</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0.5in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Revised Draft Registration Statement on Form F-1 submitted February
22, 2022</U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Prospectus Summary </U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Overview, page 1 </U></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="text-decoration: none">&nbsp;</FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">1.</FONT></TD><TD STYLE="text-align: left"><B>We note your response to comment 2. As you have identified your potential products only as seeking approval
as medical devices, revise the first sentence of the summary and throughout your prospectus to clarify you are a medical device company,
not a &quot;preclinical stage company&quot; and avoid use of terms such as &quot;preventative treatment,&quot; &quot;treatment&quot; and
&quot;prevention&quot; that imply the gel is a drug, which the FDA defines as &ldquo;a substance intended for use in the diagnosis, cure,
mitigation, <I>treatment, or prevention</I> of disease.&rdquo; Use terms that convey your potential product, if true, as a physical barrier
or shield and is drug-free. For your T&amp;T device, clarify that it is designed to deploy or convey approved drugs developed by other
companies. Provide examples of the types of ingredients in your potential product that are generally recognized as safe (&quot;GRAS&quot;).</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0in"><U>Response</U>: The Company respectfully advises
the Staff that it believes that the Company is both a medical device company and a development stage biotechnology company pursuing FDA
approval of a combination drug/device product.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">As described in greater detail in the &ldquo;Our
Products&rdquo; section of Amendment No. 2 beginning on page 74, the Company&rsquo;s leading technologies are the C&amp;C and T&amp;T
platforms. The C&amp;C technology provides a barrier against a wide range of allergen particulates and viruses. The Company expects that
its PL-14 C&amp;C platform <FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">medical device</U></FONT> product candidate (for allergy symptom
alleviation) to be regulated as a Class II medical device by the FDA under <FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">its</U></FONT>
510(k) pathway. We expect our PL-15 and PL-16 C&amp;C platform <FONT STYLE="text-underline-style: double"><U STYLE="text-decoration: none">medical device</U></FONT>
product candidates (to reduce the risk of nasal infections caused by COVID-19 and influenza, respectively) to be regulated as a Class
II medical device under a De Novo Classification request. We intend to conduct a pre-submission meeting with FDA's Center for Devices
and Radiological Health, or CRDH, to confirm the potential for this regulatory path.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">When contrasted to our C&amp;C product candidates, the gel in the
T&amp;T products is formulated differently so that its role in the T&amp;T product candidates will be to provide for sustained release
of the API. The content of the gel (quantity and quality) in the T&amp;T products are not necessarily equivalent to the content of C&amp;C
products, and therefore enable different functions: physical barrier for the C&amp;C products and API sustained release for the T&amp;T
products. It is through these differences that we rationalize the different regulatory treatment of the two product platforms.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0in">Nevertheless, in response to the Staff&rsquo;s comment,
the Company has revised the description of the Company to state that it is a &ldquo;development stage biotech company.&rdquo;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0in">In addition, we have provided examples of the types
of ingredients in our potential product that are GRAS on pages 1 and 74 of Amendment No. 2.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Tomer Izraeli<BR>
Polyrizon Ltd.<BR>
April 14, 2022<BR>
Page 3</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">2.</FONT></TD><TD STYLE="text-align: left"><B>We note the revised disclosure in response to comment 3. To the extent you believe your products are medical
devices, please revise the prospectus to eliminate references to &quot;product candidates&quot; and language implying you are developing
what could be commercialized in the future as a drug, and replace that language with &quot;medical device,&quot; and otherwise revise
your disclosure accordingly. Revise the summary to briefly describe the medical device pathway to FDA approval. In doing so, when discussing
your timeline, quantifying any timeframes to the extent practicable.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: As mentioned in the Company&rsquo;s response to Comment
No. 1 above, the Company is both a medical device company and a preclinical stage biotech company pursuing FDA approval of a combination
drug/device product. Accordingly, the Company respectfully advises the Staff that it believes the term &ldquo;product candidates&rdquo;
is appropriate in reference to the Company&rsquo;s products in development. Nevertheless, in response to the Staff&rsquo;s comment, the
Company has revised its disclosure on pages 1 and 74 of Amendment No. 2 to initially refer to its C&amp;C platform candidates as &ldquo;C&amp;C
platform medical device product candidates.&rdquo; In addition, the Company has revised its disclosure on pages 1 and 74 to describe the
medical device pathway under 510(k) for FDA approval, and discussed a timeline of this process.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>Summary Risk Factors, page 2</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="text-decoration: none"><B>&nbsp;</B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">3.</FONT></TD><TD STYLE="text-align: left"><B>Revise the summary risk factor disclosing the risk that you may be a passive foreign investment company
(&quot;PFIC&quot;) to briefly describe the potential negative U.S. federal tax consequences and provide a cross-reference to the more
detailed risk factor and material federal tax consequences disclosure. Also, clarify the risk to investors who purchase in this offering.
For example, disclose whether it is more likely than not that you will be a PFIC this year. Finally, briefly disclose the implications
for shareholders of being a PFIC.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: In response to the Staff&rsquo;s comment, the Company
has revised its disclosure on page 6 of Amendment No. 2 to briefly describe the potential negative U.S. federal tax consequences of being
a PFIC. In addition, the Company has clarified on pages 56 and 142 of Amendment No. 2 that it believes that it was likely a PFIC in 2021,
and may likely be a PFIC in the current or any subsequent taxable year.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>Risk Factors</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>Risks Related to this Offering and Ownership of Our Securities, page 12</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="text-decoration: none"><B>&nbsp;</B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">4.</FONT></TD><TD STYLE="text-align: left"><B>We note your revised disclosure on page 131 in response to comment 16. We note that your forum selection
provision identifies the &quot;competent courts of Tel Aviv, Israel&quot; as the sole and exclusive forum for certain litigation, including
any &ldquo;derivative action,&quot; and that &quot;unless you consent in writing to the selection of an alternative forum, the federal
district courts of the United States of America shall be the exclusive forum for the resolution of any complaint asserting any cause of
action under the Securities Act.&quot; You also state that &quot;[t]his provision would not apply to suits brought to enforce a duty or
liability created by the Exchange Act or to any other claim for which the U.S. federal courts have exclusive jurisdiction.&quot; Please
further clarify what will be the applicable jurisdiction for Exchange Act claims, as it currently appears that Exchange Act claims would
need to be enforced in Israel. In that regard, we note that Section 27 of the Exchange Act creates exclusive U.S. federal jurisdiction
over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section
22 of the Securities Act creates concurrent jurisdiction for U.S. federal and U.S. state courts over all suits brought to enforce any
duty or liability created by the Securities Act or the rules and regulations thereunder. Regarding the U.S. federal forum provision currently
described in your prospectus on page 131, please also revise the prospectus provide a risk factor that clearly and prominently describes
the provision, including the relevant forums for litigation and any subject matter jurisdiction carve outs, that clearly describes any
risks or other impacts to investors, including increased costs to bring a claim, that the provisions may discourage investors from bringing
claims or limit investors' ability to bring a claim in a judicial forum that they find favorable, that for claims brought in the U.S.
under the federal forum provision, there is uncertainty as to whether a court would enforce such provision and that investors cannot waive
compliance with the federal securities laws and the rules and regulations thereunder.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: In response to the Staff&rsquo;s comment, the Company
has revised its disclosure on page 132 of Amendment No. 2 to clarify that U.S. federal courts have exclusive jurisdiction over claims
brought under the Exchange Act. In addition, the Company has added a risk factor on page 58 of Amendment No. 2 to describe the risks associated
with the exclusive forum provision.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Tomer Izraeli<BR>
Polyrizon Ltd.<BR>
April 14, 2022<BR>
Page 4</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>Business</U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B><U>Overview, page 74 </U></B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="text-decoration: none"><B>&nbsp;</B></FONT></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">5.</FONT></TD><TD STYLE="text-align: left"><B>We reissue comment 10. We note the revised disclosure of your beliefs regarding the 510(c) and potential
de novo pathway for your products through the FDA approval process. Provide us support for your reasonable belief that these pathways,
and your timelines, are feasible. Tell us whether you have had any contact with the FDA to address these proposed pathways.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in"><U>Response</U>: The Company hereby
advises the Staff that its regulatory strategy regarding our conclusion about 510(k) and 510(k) de novo paths for the C&amp;C product
candidates was developed by the Company together with its regulatory advisors.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">The FDA&rsquo;s medical device
approval process under 510(k), which is explained in greater detail on page 74 of Amendment No. 2, lays out the regulatory paths for
approval for our three C&amp;C platform product candidates. For our PL-14 platform product candidate, the Company pursued the pathway
of finding an FDA-approved device that has &ldquo;substantial equivalency&rdquo; to its own product. This approval process entails performing
a medical device analysis of the product candidate, which involves analyzing the product candidate&rsquo;s description, potential accessories
and proposed use, for the purpose of finding a predicate device that has already been approved by the FDA. Through this review, the Company
found several possible predicate devices to compare its PL-14 product candidate to.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left; text-indent: 0in">With regard to its PL-15 and PL-16
product candidates, upon a review similar to the one performed for its PL-14 product candidate, the Company found that there were no valid
predicate devices in the FDA&rsquo;s database matching their intended uses. Because of this, the Company will pursue a de novo pathway,
which involves proving that the product candidates don&rsquo;t present a substantial risk to the patient. In order to assess the likelihood
of approval under a de novo pathway, the Company intends to schedule a pre-submission meeting with the FDA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The Company hereby advises the Staff that it has not yet contacted
the FDA to discuss these regulatory pathways.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">6.</FONT></TD><TD STYLE="text-align: left"><B>We note your response to comment 11. To the extent your products are not seeking approval to be marketed
as drugs, eliminate the current graphic, which has the appearance of a drug product candidate pipeline table.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: In response to the Staff&rsquo;s comment, the Company
has revised the aforementioned graphic to clarify that it is an &ldquo;FDA Clearance Roadmap&rdquo; for its C&amp;C product candidate.
The purpose of the graphic is to map out the timeline for when it will be cleared as a medical device by the FDA.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">7.</FONT></TD><TD STYLE="text-align: left"><B>We reissue comment 12, to the extent you have not identified the number of studies or the p values for
each of the charts provided. Also clarify if the charts represent one study or an average of studies. Finally, revise to clarify how the
focus on the reduction of inflammation after treatment with your compound shows that the barrier/blocking purpose of your potential product
is working, as opposed to a chemical action within the cell. That is, clarify how the study is designed to support the potential product
as a medical device rather than a drug product candidate.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>



<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: In response to the Staff&rsquo;s comment, the Company
has revised the graphics on pages 79-80 of Amendment No. 2 to provide the p values for each of the charts provided, and also clarified
that each chart represented one unique study. The Company also clarified that the polymers in its C&amp;C platform product candidates
are exceedingly big to actually penetrate the cells, and will only lay over the cells surface and therefore will not cause a chemical
action within the cell. Because the polymers do not react or interact with the cells and only cover the cells surface, the studies can
support our C&amp;C platform product candidates as medical devices.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0"></TD><TD STYLE="width: 0.5in"><FONT STYLE="text-transform: uppercase">8.</FONT></TD><TD STYLE="text-align: left"><B>We reissue comment 13 to the extent you have not removed the references to safety and effectiveness from
the prospectus. In the business section, you may present objective data resulting from testing without drawing conclusions regarding safety
and efficacy.</B></TD></TR></TABLE>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><U>Response</U>: In response to the Staff&rsquo;s comment, the Company
has revised its disclosure on pages 2, 82 and 90 to remove remaining references to safety and effectiveness from its prospectus.</P>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: left">Please contact me at +1&nbsp;312.372.2000 if you
have any questions or require any additional information in connection with this letter or the Company&rsquo;s submission of its draft
Registration Statement on Form&nbsp;F-1.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Sincerely,</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">/s/ David Huberman</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">cc: Tomer Izraeli, Chief Executive Officer</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
