SecProbe.io

CORRESP
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filename1.htm

September
7, 2017

Via
EDGAR and Courier

Amanda
Ravitz

Assistant
Director

United
States Securities and Exchange Commission

Office
of Electronics and Machinery

100
F Street, N.E.

Washington,
D.C. 20549

    Re:
    Hancock
    Jaffe Laboratories, Inc.

    Draft
    Registration Statement on Form S-1

    Submitted
    February 13, 2017

    CIK
    No. 0001661053

Dear
Ms. Ravitz:

Hancock
Jaffe Laboratories, Inc., a Delaware corporation (the “Company”), hereby provides the following information
in response to the comments received from the staff (the “Staff”) of the U.S. Securities and Exchange
Commission (the “Commission”) in its letter to the Company dated March 10, 2017 (the “Comment
Letter”). The Company’s responses are preceded by a reproduction of the Staff’s comment in italics as
set forth in the Comment Letter. In addition, the Company is concurrently filing an amended Registration Statement on Form S-1
(as amended, the “Registration Statement”).

General

    1.
    Please
    indicate whether you will be a non-accelerated filer or a smaller reporting company.

    Company
    Response: The Company expects to be a smaller reporting company and has checked the appropriate box indicating as such
    on the front cover page of the Registration Statement.

Prospectus
Cover Page

    2.

    In
    your next amendment, please revise to name the lead underwriters or advise. Please note that we may defer further review of
    the filing until the lead underwriters are named.

    Company
    Response: The Registration Statement reflects the inclusion of the Company’s underwriter, Network 1 Financial Securities,
    Inc.

    Amanda Ravitz

Page 2 of 10

    3.

    Please
    revise your prospectus summary disclosure on pages 1-10 to avoid repetition of the detail that you include later in your document.
    For example, we note that much of the disclosure in the summary appears on pages 64-74 in your document. Please also relocate
    from your prospectus summary unnecessary detail that overwhelms the most important aspects of the offering and your business
    and is more appropriate for a subsequent section of your prospectus.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the prospectus summary disclosure
    in the Registration Statement to avoid repetition and unnecessary details.

    4.
    Please
    revise throughout your prospectus to indicate the basis for each of your product claims. If your claims are not based on clinical
    studies, please revise to make that clear. If your claims are based on clinical studies, please tell us about any relationships
    you had with those studies, including whether you commissioned such studies.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
    remove or disclose the basis for each of the Company’s product claims.

    5.
    With
    a view toward balanced disclosure as to what your medical devices have shown in clinical studies, please tell us whether the
    studies have revealed any material disadvantages. Also, if your studies have not generated statistically significant long-term
    results, please balance your disclosure to make clear the significance of the absence of such results.

    Company
    Response: The Company respectfully notes the Staff’s comment and has revised its disclosures to indicate that human
    trials have not been performed.

    6.
    Please
    revise to explain your technology by avoiding the use of technical terms that may not be familiar to investors or explain
    their use in context. For example, please explain such terms as proprietary estate of processes, cumulative patency and native
    arteriovenous fistulae.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has added simplified explanations to the
    Registration Statement with the aim of making disclosures more understandable. The Company has further removed references
    to the term “propriety estate of processes” in the narrative.

Products
Under Development, page 2

    7.
    Please
    clearly explain each step you must take to reach commercialization of your products to address the billion dollar markets
    mentioned on pages 4-10. Also, disclose any material hurdles before you are able to address these markets. If such information
    is appropriate for your prospectus summary, carefully consider the information that is the most significant, and briefly highlight
    that information in the summary and include more detailed disclosure elsewhere in your document.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has included a commercialization section
    to explain the steps anticipated to reach commercialization in the Registration Statement.

    Amanda Ravitz

Page 3 of 10

Bioprosthetic
Coronary Artery Bypass Graft – CoreoGrafttm, page 3

    8.
    Please
    clarify if the market for your CoreoGraft product is intended for the population of the patients in the study (patients without
    sufficient available autologous grafts or patients with incomplete cardiac revascularization) or the larger CABG market referenced
    in the third paragraph on page 7. If you intend to compete for the entire CABG market, please add in an appropriate location
    in your prospectus how you intend to compete against the established market which uses grafts from the patient. Include appropriate
    risk factor disclosure.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and its disclosure now reflects that its initial
    target market would be “those patients without available autologous conduits.” The Company has further revised
    disclosures in the “Industry Overview” section to reflect size of market numbers in response to the Staff’s
    questions.

Intellectual
Property, page 8

    9.
    In
    an appropriate location in your prospectus, please explain how the documentation process described in the second paragraph
    of this section provides a competitive advantage and clarify why that process could not be infringed.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and its disclosure now reflects that,
    although the patent has expired on the radiation process, the experience and know-how is documented well within the Company’s
    quality program in the tissue preparation.

HJL
Venous Valve, The VenoValve, page 10

    10.
    It
    appears from your disclosure that there is presently no reimbursement code for your intended product. In an appropriate location
    in your prospectus, please indicate what steps you would have to complete in order to obtain such code and reimbursement rates
    at the range per valve disclosed in this section. Include risk factor disclosure as appropriate.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised this disclosure to indicate
    that it plans to obtain consultants to assist with the reimbursement code efforts once the first in human trial starts.

Implications
of Being an Emerging Growth Company, page 11

    11.
    Please
    supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that
    you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities
    Act, whether or not they retain copies of the communications.

    Company
    Response: The Company has not furnished any written communications to potential investors in reliance on Section 5(d)
    of the Securities Act of 1933, as amended. If and when the Company does provide such information to potential investors, the
    Company will supplementally provide the Staff with copies of all such written communications.

    Amanda Ravitz

Page 4 of 10

    12.
    Please
    reconcile your disclosure on page 11 that you have “elected to avail [y]ourselves of this extended transition period”
    with your disclosure on page 63 that you have elected not to avail yourself of the extended transition period.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
    reconcile the inconsistent statements. The Company will elect to avail itself of the extended transition period.

The
Offering, page 13

    13.
    Please
    tell us why you have not included the (i) options to purchase 2,592,000 shares of common stock and (ii) the warrants issued
    to Legend Securities, Inc. for 1,005,700 shares of Series A preferred stock, that are disclosed on page 92, in the first set
    of bullet points on this page or revise your disclosure as appropriate. Please also tell us why you assume in the second set
    of bullet points that the conversion of your preferred stock will be into an aggregate of 935,700 shares of common stock when
    you assume in other locations of your prospectus, such as on page 88, that 1,005,700 shares of common stock would be issued
    upon such conversion.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
    include the options and warrants referenced above, as well as clarify the number of shares the Company’s preferred stock
    will convert into.

Legislative
or regulatory healthcare reform measures…, page 33

    14.
    We
    note your reference to a 2.3% medical device tax. If true, please update your disclosure that this tax was suspended until
    the end of 2017 and is uncertain to take effect after that.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the Registration Statement to
    reflect the discussion of the 2.3% medical device tax to indicate that it has been suspended until 2017 and its reinstatement
    is uncertain.

Even
if we are able to commercialize any product candidates…, page 34

    15.
    Please
    revise your disclosure so that it is clear why your references to “drug companies,” “pharmacoeconomic studies”
    and “newly approved drugs” apply to your current or intended business.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosures in the Registration
    Statement to more closely relate to the Company’s business.

    Amanda Ravitz

Page 5 of 10

Industry
and Market Data, page 48

    16.
    Please
    revise to include the information missing from this section.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
    Statement to include missing information.

Use
of Proceeds, page 49

    17.
    Please
    expand the disclosure in this section to discuss the amount of proceeds from this offering that you intend to devote to the
    development of the products mentioned in the three bullet points on page 2. If any of those products may take priority over
    the other products please make that clarification as well.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
    Statement and is unable to state with certainty the amount of proceeds the Company intends to devote to each of the Company’s
    product candidates.

Capitalization,
page 51

    18.
    Please
    revise to classify the Series A preferred stock in the mezzanine, consistent with the presentation in your financial statements.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised this section in the Registration
    Statement accordingly.

Results
of Operations, page 56

    19.
    Please
    expand to explain the reasons for the gross loss on revenues from LeMaitre and clarify whether you expect to continue to realize
    losses under the arrangement.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has expanded the disclosure in this section
    of the Registration Statement to explain the reason for the Company’s losses under its arrangement with LeMaitre Vascular,
    Inc. (“LMAT”), and its go forward expectations.

Overview,
page 64

    20.
    Based
    on your disclosure on page 54 that the agreement with Cryolife, Inc. was terminated, please update your disclosure here regarding
    that agreement and clarify how your currently derive your “ongoing revenue stream.”

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has expanded the disclosure in this section
    in the Registration Statement to clarify that the Company derives its ongoing revenue stream from the sub-contract manufacture
    of product for LMAT and royalties earned on LMAT sales, pursuant to the agreement with LMAT.

    Amanda Ravitz

Page 6 of 10

Bioprosthetic
Coronary Artery Bypass Graft Device Need, page 66

    21.
    We
    note your disclosure that “a significant cost of CABG procedures is associated with graft harvest and the extended recovery
    and complications related to the harvest procedure.” We also note your disclosure that your device that substitutes
    for graft harvest would be priced at between $6,000 and $7,000 per unit. To the extent known, please disclose how your product
    cost compares to the current cost of patient graft harvest.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to explain that
    less morbidity, shorter hospital stays, shorter surgery and fewer  assistants because of this product use will
    result     in cost savings.

Bioprosthetic
Coronary Artery Bypass Graft — CoreoGrafttm, page 69

    22.
    Please
    disclose the intended end-points of the human clinical trials that you plan to begin in 2017.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to indicate that
    the endpoint of the trials will be based on patient survival and graft survival after one year and the clinical trial will
    begin in 2018.

Management,
page 75

    23.
    Please
    revise to ensure that you have disclosed the principal occupations and employment of Dr. Glickman and Messrs. Anderson, Doyle
    and Alferenko during the past five years. Also, revise to include the information missing from the fourth paragraph on page
    77.

    Company
    Response: The Company respectfully acknowledges the Staff’s comment and has revised its disclosure to indicate the
    principal occupations and employment of its directors. The Company respectfully notes that Mr. Alferenko is no longer a member
    of the Company’s board of directors and is no longer referenced in this section.

    24.
    Please
    disclose the principal business of Biodyne Holding SA and whether Mr. Zhivilo may have any conflicts of interest with your
    company as a result of his affiliation with Biodyne.

    Company
    Response: The Company has revised the Registration Statement to disclose that Biodyne Holding, S.A.’s (“Biodyne”),
    principal line of business is to invest in medical device technology companies. While the Company does not believe that Mr.
    Zhivilo currently has any conflict of interest with the Company as a result of his affiliation with Biodyne, the Company cannot
    predict, ascertain or comment on any future conflict of interests that may arise out of Mr. Zhivilo’s association with
    both the Company and Biodyne. Accordingly, the Company has not revised the Registration Statement to disclose any current
    or future conflict of interest.

    Amanda Ravitz

Page 7 of 10

Hancock
Jaffe Laboratories Aesthetics, Inc., page 89

    25.
    Please