Minimally Invasive Laparoscopic Retractor

Assaf Livne, CEODecember 2017

Legal disclaimerIMPORTANT NOTICEThis presentation has been prepared by LapSpace Medical Ltd. (the Company) solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be complete or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. The Company has prepared this presentation based on information available to it, including information derived from public sources that have not been independently verified. The Company makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any errors omissions in, this presentation. This presentation includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. This presentation may contain statements that are not historical facts, referred to as forward looking statements. The Companys actual future results may differ materially from those suggested by such statements. No assurance can be given that future events will occur or that projections will be achieved. Past performance isnot a reliable indication of future performance. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of the Companys securities, or an offer to sell, or a solicitation of an offer to buy, the Companys securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. Prospective investors should not construe the contents of this presentation as business, legal, tax, investment or other advice. Each prospective investor should make his, her or its own inquiries and consult his, her or its own advisorsas to the appropriateness and desirability of an investment in the Company and as to business, legal, tax and related mattersconcerning an investment in the Company.An investment in the Company shall be allowed only to such number and category of investors in accordance with applicable laws and regulations and pursuant to a predetermined process. Accordingly, detailed information in connection with the investment shall be revealed and delivered only to a limited number of qualifying investors as provided by law.

Main Achievements

Regulatory Approvals in place

Product successfully used in over 500 surgical

procedures

Patents in the US, Japan, and China

sales in Europe

What is Laparoscopic Surgery?

Laparoscopic surgery: performed through tiny holes made in the body; surgeon has limited view

of the operating site

Open surgery: the surgeon makes a long

incision and has a clear view of the operating site

Success depends on optimal exposure of the operating site

The Laparoscopic Challenges

Limited view of the operating field Rigid retractors may cause organ damage Tilting the surgical table may cause post-operative

complications

Existing retracting techniques are inefficient

Titling the surgical table to improve visual field

Retractors to push aside the organs

LapSpace: Safe Retraction for Optimal View

Improved visibility No organ damage Reduced complications Shortened procedure time Reduced hospital costs

LapSpaces inflatable retractor

very intuitiveIts like an extension of

our hand inside the body

LapSpaces inflatable retractor

LapSpaces Product Family

SPro10MiniPro10Medium

LapSpaces devices come in four different balloon sizes ranging from 85 to 120mm to provide surgeons maximum versatility

KOLs are exited and involved

I spend 10% of my surgical time clearing the view to expose the target organ. I would use the LapSpace retractor in 25% to 50% of

my surgeries.Dr. Guy Voeller, Baptist Memorial Hospital

Professor of SurgeryUniversity of Tennessee

Strong need in 75% of gastrointestinal surgeries.Dr. Steven Schwaitzberg, Harward

General surgery MISCambridge Health Alliance (Massachusetts)

"During some of the thousands of laparoscopic procedures I performed, I would have given anything for an extra hand inside the abdomen for retraction. The LapSpace retractor meets that

need.Dr. David Earle, Baystate Medical Center

Associate Professor of SurgeryTufts University School of Medicine

I spend 15% of my time clearing the view. I would use LapSpace in about 80% of my cases.

Dr. Shawn Tsuda, Univ. of Nevada General Surgeon and Assistant Professor

University of Nevada, Las Vegas

Clinical Study Johns Hopkins Univ.

9

FUTURE RESEARCH Transition to an analytic RCT study in

order to corroborate initial findings and provide launching points for further studies

Further investigation into how this device can improve on efficacy, time, and costs of laparoscopic operations

BACKGROUNDSuccess of any laparoscopic surgery relies on optimalexposure of the operative site. In operations, surgeonsand assistants are required to tightly strap the patientson the surgical bed but must continuously change thepatients position and manipulate bowels usinggraspers to keep organs from obstructing view of thesite. Smaller bowels and organs, however, are not ableto be held back efficiently using these techniques andslide continuously into the operating area. Currently,maneuvers such as the Trendelenburg as well asmetallic instruments are used to clear abdominalorgans from the operating field, but are only partiallyeffective and can cause unintentional trauma to thepatient. Therefore, it is of importance in laparoscopicsurgeries that instruments must optimally reveal thesurgical site while ensuring that the surroundingbowels and organs are kept away safely in place.

TESTING & RESULTS

A NOVEL INFLATABLE AND RETRACTING LAPAROSCOPIC DEVICE THAT PROVIDES MAXIMAL EXPOSURE OF THE OPERATIVE FIELD Ambar Mehta1, Anirudh Dwarakanath MS2, Rohith M Bhethanabotla3, Hien T Nguyen MD1,2,

1Johns Hopkins University School of Medicine, 2Johns Hopkins Bayview Medical Center Department of Surgery, 3Johns Hopkins University, Whiting School of Engineering

LAPSPACEThe LapSpace laparoscopic retractor is placed through a 10-mm trocar and controls an inflatable balloon at its tip. Once the device is inside the abdomen, the surgeon inflates the balloon and surgeons can control its positioning and retraction angle. A bed clamp provides permanent retraction and hands-free utilization. The balloon itself is a biocompatible polymer, made of nylon fibers and thermoplastic polyurethane, which is atraumatic to tissue and can hold sufficient tension and pressure. The retractor minimizes mobilization of the small intestines and stabilizes the abdominal organs.

OBJECTIVESTo evaluate the safety and feasibility ofLapSpace, an innovative, FDA-approved,laparoscopic device with an inflatable elementthat can retract abdominal contents forcreating and maintaining optimal exposure ofthe operative field.

STUDY METHODSSample Size: The study contained 20 patients over 1 year.Conditions for Study: Patient participants were informed that we are using a novel device in their operation. Those who did not wish to give consent were not enrolled in the study. Also, any evidence of safety or inefficiency during the operation terminated its use.Post-Surgical Evaluation: Operative time and surgeon feedback were evaluated with a LapSpace-designed post-surgical survey, which compared operations performed with and without LapSpace.

CONCLUSIONThe LapSpace inflatable retractor, with itsnovel inflatable component and manually-controlled retractor, has initiallydemonstrated versatility in a wide varietyof operations, in providing an optimaloperating field, and in reducing inadvertenttissue injuries. It has also received strongapproval by the surgeons using theinstrument in comparison to the statusquo. Due to the utility of this device, thereis potential for it to become commonlyused in many different types of minimallyinvasive procedures.

LIMITATIONS Study was a descriptive survey-based

study that was intended to assess feasibility and safety

Further quantitative studies will be needed to determine superiority over prior art

Greater sample size necessary and a more elaborate measure to model inter-rater reliability

0 0

3

1

10

1

2

1

13

0

2

4

6

8

10

12

14

Num

ber o

f Sur

gerie

s

Type of Surgery

Surgeries that used Lapspace Retractor

Total HysterectomyCholecystectomySleeve Gastrectomyileal InterpositionNissen FundoplicationAdrenalectomyHerniorrhaphy

A 15-question survey collected the surgeons feedback on the devices safety, utility, ergonomics, and satisfaction. The surgeons overwhelmingly stated that this device provides optimal exposure of the operating field, minimizes risks of inadvertent tissue injuries, and reduces the tilt or the time spent by the patient in the Trendelenburg position. Each surgeon was satisfied with the ergonomics of the handle and noted that they would use the device again. Only one surgeon experienced minor difficulties with deflating the balloon completely.

FUTURE RESEARCH

Transition to an analytic RCT study in order to corroborate initial findings and provide launching points for further studies

Further investigation into how this device can improve on efficacy, time, and costs of laparoscopic operations

BACKGROUND

Success of any laparoscopic surgery relies on optimal exposure of the operative site. In operations, surgeons and assistants are required to tightly strap the patients on the surgical bed but must continuously change the patients position and manipulate bowels using graspers to keep organs from obstructing view of the site. Smaller bowels and organs, however, are not able to be held back efficiently using these techniques and slide continuously into the operating area. Currently, maneuvers such as the Trendelenburg as well as metallic instruments are used to clear abdominal organs from the operating field, but are only partially effective and can cause unintentional trauma to the patient. Therefore, it is of importance in laparoscopic surgeries that instruments must optimally reveal the surgical site while ensuring that the surrounding bowels and organs are kept away safely in place.

TESTING & RESULTS

A NOVEL INFLATABLE AND RETRACTING LAPAROSCOPIC DEVICE THAT PROVIDES

MAXIMAL EXPOSURE OF THE OPERATIVE FIELD

Ambar Mehta1, Anirudh Dwarakanath MS2, Rohith M Bhethanabotla3, Hien T Nguyen MD1,2,

1Johns Hopkins University School of Medicine, 2Johns Hopkins Bayview Medical Center Department of Surgery, 3Johns Hopkins University, Whiting School of Engineering

LAPSPACE

The LapSpace laparoscopic retractor is placed through a 10-mm trocar and controls an inflatable balloon at its tip. Once the device is inside the abdomen, the surgeon inflates the balloon and surgeons can control its positioning and retraction angle. A bed clamp provides permanent retraction and hands-free utilization. The balloon itself is a biocompatible polymer, made of nylon fibers and thermoplastic polyurethane, which is atraumatic to tissue and can hold sufficient tension and pressure. The retractor minimizes mobilization of the small intestines and stabilizes the abdominal organs.

OBJECTIVES

To evaluate the safety and feasibility of LapSpace, an innovative, FDA-approved, laparoscopic device with an inflatable element that can retract abdominal contents for creating and maintaining optimal exposure of the operative field.

STUDY METHODS

Sample Size: The study contained 20 patients over 1 year.

Conditions for Study: Patient participants were informed that we are using a novel device in their operation. Those who did not wish to give consent were not enrolled in the study. Also, any evidence of safety or inefficiency during the operation terminated its use.

Post-Surgical Evaluation: Operative time and surgeon feedback were evaluated with a LapSpace-designed post-surgical survey, which compared operations performed with and without LapSpace.

CONCLUSION

The LapSpace inflatable retractor, with its novel inflatable component and manually-controlled retractor, has initially demonstrated versatility in a wide variety of operations, in providing an optimal operating field, and in reducing inadvertent tissue injuries. It has also received strong approval by the surgeons using the instrument in comparison to the status quo. Due to the utility of this device, there is potential for it to become commonly used in many different types of minimally invasive procedures.

LIMITATIONS

Study was a descriptive survey-based study that was intended to assess feasibility and safety

Further quantitative studies will be needed to determine superiority over prior art

Greater sample size necessary and a more elaborate measure to model inter-rater reliability

A 15-question survey collected the surgeons feedback on the devices safety, utility, ergonomics, and satisfaction. The surgeons overwhelmingly stated that this device provides optimal exposure of the operating field, minimizes risks of inadvertent tissue injuries, and reduces the tilt or the time spent by the patient in the Trendelenburg position. Each surgeon was satisfied with the ergonomics of the handle and noted that they would use the device again. Only one surgeon experienced minor difficulties with deflating the balloon completely.

*Do we have any more data that needs to be added?

*Not sure what else to put under Future Research

*I know its not very pretty. Want to get the content right before making aesthetic changes

1

Surgeries that used Lapspace Retractor

Use of Lapspace Retractor in SurgeryType of SurgeryTotal Hysterectomy CholecystectomySleeve Gastrectomyileal InterpositionNissen FundoplicationAdrenalectomyHerniorrhaphy0311012113

Type of Surgery

Number of Surgeries

Strong Patent Protection

Granted patents in the US (2 patents), China and Japan 3 patents registered IP strategy with Finnegan (US firm) FTO process with Greenberg Traug (US firm)

1010

Regulatory & Reimbursement in Place

Received FDA 510(k) clearance Received CE Mark Japan Ongoing Reimbursement: existing, part of DRG

1111

Large, Growing Market Potential

US and EU ~10 million laparoscopic procedures market growing 5% yearly

China ~ 10 million laparoscopic procedures market growing 10% yearly

Assuming LapSpace is used in 50% of cases*, with a product price of US$150

12 * According to customer survey

5 mm

Development is almost accomplished.

13

www.lapspacemedical.com

Assaf Livne, CEOassaf@lapspacemedical.com

mailto:assaf@lapspacemedical.com

Slide Number 1Legal disclaimerSlide Number 3Slide Number 4The Laparoscopic ChallengesSlide Number 6LapSpaces Product FamilyKOLs are exited and involvedClinical Study Johns Hopkins Univ. Strong Patent ProtectionRegulatory & Reimbursement in PlaceSlide Number 125 mm Slide Number 14